ID

30546

Beschreibung

This ODM file contains Eligibility Criteria. To be filled in at Screening. Do an Inclusion/Exclusion Check at Sessions 1 and 2 (Day -1). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Stichworte

Versionen (1)
  1. 13.06.18 13.06.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. Juni 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Type of Visit
Beschreibung

Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beschreibung

To be answered at screening. If No, fill in the items of Inclusion and Exclusion criteria. Answer "no" corresponding to violations of any inclusion criteria, "yes" corresponding to violations of any Exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Datentyp

text

Alias
UMLS CUI [1]
C1302261
Inclusion/Exclusion Criteria Check
Beschreibung

Inclusion/Exclusion Criteria Check

Alias
UMLS CUI-1
C0013893
Is the subject eligible to continue the study?
Beschreibung

To be answered at Day -1 of Sessions.

Datentyp

text

Alias
UMLS CUI [1]
C1302261
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, psychiatric history, psychiatric evaluation, laboratory tests and cardiac monitoring.
Beschreibung

A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to compromise subject safety or interfere with study integrity. Subjects with elevated prolactin values outside the normal range should always be excluded from enrollment.

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0373706
UMLS CUI [2,2]
C0205307
Male or female between 18 and 45 years of age inclusive.
Beschreibung

Selected to encompass subjects without significant chance of brain function decline due to age.

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Subjects are eligible if they are willing to be referred to a dietician.
Beschreibung

Referral to dietician

Datentyp

boolean

Alias
UMLS CUI [1]
C0420347
Must be right handed.
Beschreibung

a requirement to ensure consistency of fMRI signals from the brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0344333
A female subject is eligible to participate if she is of non-childbearing potential or if she agrees to use one of the listed contraception methods.
Beschreibung

Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) will not be included in the study. Child-bearing potential and agrees to use one of the contraception methods listed for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 90 days after completion of the study. If female subjects are currently using oral or depot hormonal contraceptives, they may be enrolled but must also use one other form of contraception as listed. List of contraceptive methods with failure rate below 1 percent: * Abstinence: Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Intrauterine device (IUD) or intrauterine system (IUS) that meets the under 1 percent failure rate as stated in the product label. * Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. * Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository).

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Male subjects must agree to use one of the contraception methods listed.
Beschreibung

This criterion must be followed from the time of the first dose of study medication until 90 days after completion of the study. List: * Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Double barrier method: condom plus spermicidal agent (foam/gel/film/cream/suppository).

Datentyp

boolean

Alias
UMLS CUI [1]
C0086580
BMI within the range 27 – 40 kg/m2 (inclusive) and body habitus consistent with comfort during scanning.
Beschreibung

BMI 27-40, comfortable body habitus

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C1318474
UMLS CUI [2,2]
C1331418
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Beschreibung

(Capable of) Written informed consent, Compliance with study requirements

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2698977
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C2698977
QTcB or QTcF < 450 msec.
Beschreibung

QTcB or QTcF < 450 msec.

Datentyp

boolean

Alias
UMLS CUI [1]
C1882512
UMLS CUI [2]
C1882513
Self-administered Beck Depression Inventory II scale total score no greater than 13, and suicide question score of zero.
Beschreibung

Beck Depression Inventory II < 13, Suicide question score = 0

Datentyp

boolean

Alias
UMLS CUI [1]
C4273555
UMLS CUI [2,1]
C0038661
UMLS CUI [2,2]
C0681889
Subjects are eligible to take part in the study if they binge eat (i.e. minimum 1 binge episode per week).
Beschreibung

Binge eating

Datentyp

boolean

Alias
UMLS CUI [1]
C0596170
Subjects are eligible if they score at least 3 in at least one of questions of the emotional eating scale (Q3, Q6 and Q10) of the TFEQ-R18.
Beschreibung

TFEQ-R18 (Q3, Q6 and/or Q10 at least 3)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0013473
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
The subject has either a previous disease or current medical condition, which as judged by the Investigator, may affect the interpretation of efficacy data.
Beschreibung

These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, psychiatric diseases or endocrine disease.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0459471
A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Beschreibung

(with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies).

Datentyp

text

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0920548
The subject has a current closed angle glaucoma.
Beschreibung

closed angle glaucoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0017605
The subject has prostatic hyperplasia.
Beschreibung

prostatic hyperplasia

Datentyp

boolean

Alias
UMLS CUI [1]
C2937421
The subject has a known history of panic attacks and/or claustrophobia, or other conditions precluding MRI scans according to local guidelines.
Beschreibung

e.g. pacemaker, hearing aid, tattoos, metallic body piercing and/or other metal implants that cannot be removed.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
The subject has a history or presence of other neurological or other psychiatric or other medical conditions that may influence the outcome or analysis of the scan results.
Beschreibung

Examples of such include, but are not limited to: schizophrenia or psychosis, major depressive disorder, anxiety disorders, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack, rheumatoid arthritis and fibromyalgia syndrome.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0004936
UMLS CUI [1,4]
C0024485
UMLS CUI [1,5]
C4054723
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0024485
UMLS CUI [2,3]
C4054723
The subject has a history of anorexia nervosa, binge-eating disorder without obesity or bulimia nervosa.
Beschreibung

Anorexia nervosa, Bulimia nervosa, Binge eating without obesity

Datentyp

boolean

Alias
UMLS CUI [1]
C0003125
UMLS CUI [2]
C2267227
UMLS CUI [3,1]
C0596170
UMLS CUI [3,2]
C0028754
UMLS CUI [3,3]
C1298908
The subject has a recent history of weight loss (or gain) defined as a change of >5 percent in the 3 months prior to screening or those who have lost >5 percent of their body weight in the past 30 days.
Beschreibung

Weight loss or gain > 5 percent in last 3 months

Datentyp

boolean

Alias
UMLS CUI [1]
C0005911
The subject has had surgical intervention for obesity.
Beschreibung

obesity surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C2112820
The subject has a history of alcohol or substance abuse or dependence in the 6 months prior to screening as determined by the investigator.
Beschreibung

Abuse of alcohol, defined for males, as an average weekly intake of greater than 21 units (or an average daily intake of greater than 3 units), or defined for females, as an average weekly intake of greater than 14 units (or an average daily intake of greater than 2 units). One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0038580
UMLS CUI [4]
C0740866
Current smokers as determined by urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Beschreibung

Cotinine levels, History of smoking

Datentyp

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C0202363
The subject has a positive urine drug test at screening or when tested at any of the study visits.
Beschreibung

Drug screen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
The subject has a documented history of hepatobiliary disease or hepatic enzyme elevation including any one of the following: ALT or AST > 2 times upper limit of normal at screening or Day -1. Fasting triglycerides > 600mg/dL at screening or Day -1. Total bilirubin > 1.5 times the upper limit of normal at screening or Day -1.
Beschreibung

Subjects above this limit may only be included if direct bilirubin is within normal limits, which would be consistent with Gilbert’s disease.

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0582824
If a subject is receiving lipid-lowering therapy (i.e. statins).
Beschreibung

Lipid-lowering therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0585943
The subject has known type 1 or type 2 diabetes mellitus; or has fasting plasma glucose >140mg/dL (7.5mmol/L) at screening, or is on an oral glycemic agent.
Beschreibung

Diabetes mellitus Type 1/2, fasting plasma glucose, oral glycemic agent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0583513
UMLS CUI [4]
C0421247
The subject at screening has systolic blood pressure (BP) below 90 or above 150mmHg, or diastolic blood pressure (BP) below 50 or above 100 mmHg.
Beschreibung

Systolic or diastolic blood pressure above/below limits

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
Planning to commence or stop hormone replacement therapy (HRT) or oral contraceptives during the course of the study.
Beschreibung

Female subjects who are taking an oral contraceptive preparation at the time of screening may be eligible for enrolment in the study, however they must use additional forms of contraception.

Datentyp

boolean

Alias
UMLS CUI [1]
C0009905
UMLS CUI [2]
C3274784
UMLS CUI [3]
C3274784
UMLS CUI [4]
C0850893
The subject is pregnant (as determined by positive serum or urine hCG test at screening or prior to dosing) or planning a pregnancy in the following 27 weeks from screening.
Beschreibung

current or planned pregnancy, hCG test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0546577
UMLS CUI [2]
C0032992
Lactating females or lactating within the last month.
Beschreibung

Lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C2828358
The subject has concomitant medications usage that includes medication listed in the description.
Beschreibung

* use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication with the exception of occasional non-daily use of acetaminophen, or non-steroidal anti-inflammatory agents. * Use of weight loss drugs within three months of the first dose of the marketed drug. * Use of any oral anti-diabetic medication (including metformin, sulphonylureas, thiazolidinedione, GLP-1 agonist, DDP-IV inhibitors). * Use of antidepressants or anxiolytics (selective serotonin re-uptake inhibitor (SSRI), tricyclic, buprion, sedatives, hypnotics) on any basis other than occasional within 6 months of screening. * Use of antipsychotics (i.e. D2 antagonists) or any dopamine agonists (i.e. bromocriptine, pergolide) or Parkinson’s disease medications (L-DOPA) ever * Use of diuretics, systemic corticosteroids (inhaled and intranasal corticosteroids are permitted), or any other medication within 3 weeks prior to any scheduled dose of study medication that may result in electrolyte depletion. * Use of macrolide antibiotics during the interventional part of the study. Medications not allowed: At least 6 months prior to the Baseline Visit: All antidepressants, Lithium At least 2 weeks prior to Baseline visit (or 5 half-lives whichever is longer): Psychoactive herbal or nutritional treatment (e.g., St. John's Wort, SAM-e), Opiates, hypnotics, anxiolytics, and all other sedatives (including as needed benzodiazepines as sleep aids), Systemic corticosteroids (NOTE: Topical hydrocortisone, inhaled and nasal corticosteroids are allowed). Concomitant medications that are known potent or moderate inducers or inhibitors of CYP3A4/5 for 14 days prior to administration randomization through 14 days after the last dose of investigational product: CYP3A4/5 Inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil (Intermittent use of topical/vaginal antifungal medications are permitted), CYP3A4/5 Inducers: carbamazepine, phenobarbitol, phenytoin, rifabutin, rifampicin, St John’s Wort. Please note that this is not an exhaustive list.

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
The subject has used any investigational drug or device in the 30 days prior to first dose of study medication or was exposed to more than four new chemical entities within 12 months prior to the first dosing day.
Beschreibung

Investigational drug or device in last 12 months

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C2346570
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Beschreibung

Sensitivity to study medication, other (drug) allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C0013182
UMLS CUI [3]
C0020517
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Beschreibung

Study participation resulting in Blood donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C2348568
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
Beschreibung

Red wine, seville oranges, grapefruit (juice)

Datentyp

boolean

Alias
UMLS CUI [1]
C0995150
UMLS CUI [2]
C0452456
UMLS CUI [3]
C0349371
UMLS CUI [4]
C0330922
The subject has a serum prolactin at screening exceeding the normal range.
Beschreibung

Serum Prolactin

Datentyp

boolean

Alias
UMLS CUI [1]
C0373706
Positive history of psychiatric disorder by DSM-IV Axis I or II, or positive findings on psychiatric evaluation other than binge eating that does not meet the DSM-IV diagnostic criteria for binge eating disorder.
Beschreibung

DSM-IV Axis I or II

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0220952
UMLS CUI [2,1]
C0270288
UMLS CUI [2,2]
C0220952
UMLS CUI [3]
C0596170
The subject has personal or family history of prolonged QTc, a personal history of arrhythmia, a history of sudden unexplained death in a first degree relative, or unexplained syncope in a first degree relative.
Beschreibung

QTc prolonged, arrhythmia, sudden unexplained death/syncope in first degree relative

Datentyp

boolean

Alias
UMLS CUI [1]
C1969409
UMLS CUI [2,1]
C0011071
UMLS CUI [2,2]
C1517194
UMLS CUI [3,1]
C1517194
UMLS CUI [3,2]
C0039070
UMLS CUI [4]
C0003811
Unwillingness or inability to follow the procedures outlined in the protocol.
Beschreibung

Protocol compliance unwilling/unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
The subject has healthy food preferences (including vegetarians) based on a food preference questionnaire.
Beschreibung

Healthy food preference

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016483
UMLS CUI [1,2]
C3898900
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Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Type of Visit
text
C0545082 (UMLS CUI [1])
Visit
Code List
Type of Visit
CL Item
Screening (Screening)
(Comment:en)
CL Item
Session 1 (Day -1) (Session 1)
(Comment:en)
CL Item
Session 2 (Day -1) (Session 2)
(Comment:en)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1302261 (UMLS CUI [1])
Eligible
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion/Exclusion Criteria Check
C0013893 (UMLS CUI-1)
Item
Is the subject eligible to continue the study?
text
C1302261 (UMLS CUI [1])
Eligible
Code List
Is the subject eligible to continue the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Healthy with normal prolactin values
Item
Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, psychiatric history, psychiatric evaluation, laboratory tests and cardiac monitoring.
boolean
C1708335 (UMLS CUI [1])
C0373706 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Gender, Age
Item
Male or female between 18 and 45 years of age inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Referral to dietician
Item
Subjects are eligible if they are willing to be referred to a dietician.
boolean
C0420347 (UMLS CUI [1])
Right handed
Item
Must be right handed.
boolean
C0344333 (UMLS CUI [1])
Non-childbearing potential or contraception method
Item
A female subject is eligible to participate if she is of non-childbearing potential or if she agrees to use one of the listed contraception methods.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Male: Contraception methods
Item
Male subjects must agree to use one of the contraception methods listed.
boolean
C0086580 (UMLS CUI [1])
BMI 27-40, comfortable body habitus
Item
BMI within the range 27 – 40 kg/m2 (inclusive) and body habitus consistent with comfort during scanning.
boolean
C1305855 (UMLS CUI [1])
C1318474 (UMLS CUI [2,1])
C1331418 (UMLS CUI [2,2])
(Capable of) Written informed consent, Compliance with study requirements
Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
QTcB or QTcF < 450 msec.
Item
QTcB or QTcF < 450 msec.
boolean
C1882512 (UMLS CUI [1])
C1882513 (UMLS CUI [2])
Beck Depression Inventory II < 13, Suicide question score = 0
Item
Self-administered Beck Depression Inventory II scale total score no greater than 13, and suicide question score of zero.
boolean
C4273555 (UMLS CUI [1])
C0038661 (UMLS CUI [2,1])
C0681889 (UMLS CUI [2,2])
Binge eating
Item
Subjects are eligible to take part in the study if they binge eat (i.e. minimum 1 binge episode per week).
boolean
C0596170 (UMLS CUI [1])
TFEQ-R18 (Q3, Q6 and/or Q10 at least 3)
Item
Subjects are eligible if they score at least 3 in at least one of questions of the emotional eating scale (Q3, Q6 and Q10) of the TFEQ-R18.
boolean
C0034394 (UMLS CUI [1,1])
C0013473 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Disease affecting interpretation of efficacy
Item
The subject has either a previous disease or current medical condition, which as judged by the Investigator, may affect the interpretation of efficacy data.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
HIV, Hepatitis B surface antigen, Hepatits C antibody: positive
Item
A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
text
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
closed angle glaucoma
Item
The subject has a current closed angle glaucoma.
boolean
C0017605 (UMLS CUI [1])
prostatic hyperplasia
Item
The subject has prostatic hyperplasia.
boolean
C2937421 (UMLS CUI [1])
MRI contraindication
Item
The subject has a known history of panic attacks and/or claustrophobia, or other conditions precluding MRI scans according to local guidelines.
boolean
C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
Psychiatric/neurological/medical condition influencing outcome or MRI analysis
Item
The subject has a history or presence of other neurological or other psychiatric or other medical conditions that may influence the outcome or analysis of the scan results.
boolean
C0009488 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C4054723 (UMLS CUI [1,5])
C0027765 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C4054723 (UMLS CUI [2,3])
Anorexia nervosa, Bulimia nervosa, Binge eating without obesity
Item
The subject has a history of anorexia nervosa, binge-eating disorder without obesity or bulimia nervosa.
boolean
C0003125 (UMLS CUI [1])
C2267227 (UMLS CUI [2])
C0596170 (UMLS CUI [3,1])
C0028754 (UMLS CUI [3,2])
C1298908 (UMLS CUI [3,3])
Weight loss or gain > 5 percent in last 3 months
Item
The subject has a recent history of weight loss (or gain) defined as a change of >5 percent in the 3 months prior to screening or those who have lost >5 percent of their body weight in the past 30 days.
boolean
C0005911 (UMLS CUI [1])
obesity surgery
Item
The subject has had surgical intervention for obesity.
boolean
C2112820 (UMLS CUI [1])
Alcohol or substance abuse or dependence
Item
The subject has a history of alcohol or substance abuse or dependence in the 6 months prior to screening as determined by the investigator.
boolean
C0085762 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0740866 (UMLS CUI [4])
Cotinine levels, History of smoking
Item
Current smokers as determined by urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
boolean
C1519384 (UMLS CUI [1])
C0202363 (UMLS CUI [2])
Drug screen positive
Item
The subject has a positive urine drug test at screening or when tested at any of the study visits.
boolean
C0743300 (UMLS CUI [1])
ALT, AST, Fasting TAG, total bilirubin
Item
The subject has a documented history of hepatobiliary disease or hepatic enzyme elevation including any one of the following: ALT or AST > 2 times upper limit of normal at screening or Day -1. Fasting triglycerides > 600mg/dL at screening or Day -1. Total bilirubin > 1.5 times the upper limit of normal at screening or Day -1.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0582824 (UMLS CUI [4])
Lipid-lowering therapy
Item
If a subject is receiving lipid-lowering therapy (i.e. statins).
boolean
C0585943 (UMLS CUI [1])
Diabetes mellitus Type 1/2, fasting plasma glucose, oral glycemic agent
Item
The subject has known type 1 or type 2 diabetes mellitus; or has fasting plasma glucose >140mg/dL (7.5mmol/L) at screening, or is on an oral glycemic agent.
boolean
C0011860 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0583513 (UMLS CUI [3])
C0421247 (UMLS CUI [4])
Systolic or diastolic blood pressure above/below limits
Item
The subject at screening has systolic blood pressure (BP) below 90 or above 150mmHg, or diastolic blood pressure (BP) below 50 or above 100 mmHg.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Start/Stop HRT or oral contraceptives
Item
Planning to commence or stop hormone replacement therapy (HRT) or oral contraceptives during the course of the study.
boolean
C0009905 (UMLS CUI [1])
C3274784 (UMLS CUI [2])
C3274784 (UMLS CUI [3])
C0850893 (UMLS CUI [4])
current or planned pregnancy, hCG test
Item
The subject is pregnant (as determined by positive serum or urine hCG test at screening or prior to dosing) or planning a pregnancy in the following 27 weeks from screening.
boolean
C0032961 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
C0032992 (UMLS CUI [2])
Lactating
Item
Lactating females or lactating within the last month.
boolean
C2828358 (UMLS CUI [1])
Concomitant medication
Item
The subject has concomitant medications usage that includes medication listed in the description.
boolean
C2347852 (UMLS CUI [1])
Investigational drug or device in last 12 months
Item
The subject has used any investigational drug or device in the 30 days prior to first dose of study medication or was exposed to more than four new chemical entities within 12 months prior to the first dosing day.
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C2346570 (UMLS CUI [1,3])
Sensitivity to study medication, other (drug) allergy
Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2])
C0020517 (UMLS CUI [3])
Study participation resulting in Blood donation
Item
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
boolean
C0005794 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Red wine, seville oranges, grapefruit (juice)
Item
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
boolean
C0995150 (UMLS CUI [1])
C0452456 (UMLS CUI [2])
C0349371 (UMLS CUI [3])
C0330922 (UMLS CUI [4])
Serum Prolactin
Item
The subject has a serum prolactin at screening exceeding the normal range.
boolean
C0373706 (UMLS CUI [1])
DSM-IV Axis I or II
Item
Positive history of psychiatric disorder by DSM-IV Axis I or II, or positive findings on psychiatric evaluation other than binge eating that does not meet the DSM-IV diagnostic criteria for binge eating disorder.
boolean
C0270287 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0270288 (UMLS CUI [2,1])
C0220952 (UMLS CUI [2,2])
C0596170 (UMLS CUI [3])
QTc prolonged, arrhythmia, sudden unexplained death/syncope in first degree relative
Item
The subject has personal or family history of prolonged QTc, a personal history of arrhythmia, a history of sudden unexplained death in a first degree relative, or unexplained syncope in a first degree relative.
boolean
C1969409 (UMLS CUI [1])
C0011071 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C1517194 (UMLS CUI [3,1])
C0039070 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
Protocol compliance unwilling/unable
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Healthy food preference
Item
The subject has healthy food preferences (including vegetarians) based on a food preference questionnaire.
boolean
C0016483 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
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