ID

44099

Description

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Eligibility Criteria.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Keywords

  1. 12/16/16 12/16/16 -
  2. 4/19/18 4/19/18 - Sarah Riepenhausen
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

Eligibility Criteria

  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Did the male or female subject age 18-65 years, inclusive, meet the diagnostic criteria for schizophrenia as defined in DSM-IV-TR?
Description

This diagnosis can include 295.10 (Disorganized type), 295.20 (Catatonic type), 295.30 (Paranoid type) and 295.90 (Undifferentiated type).

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0220952
UMLS CUI [2]
C0001779
Is the female eligible to enter and participate in this study?
Description

a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal); or, b) child-bearing potential, has a negative serum pregnancy test at screen, and agrees to one of the following: 1. Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for 5 days after completion or early withdrawal from the study to account for elimination of the study drug. 2. Should a subject decide to become sexually active during the course of the study, she must be counseled and be willing to use one of the methods listed below to continue in the study: 2.1 Female sterilization or, 2.2 Sterilization of male partner and who is the sole sexual partner for that female subject or, 2.3 Implants of levonorgestrel or, 2.4 Injectable progestogen or, 2.5 Oral contraceptive (combined or progesterone only) or, 2.6 Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is < 1% per year (not all IUDs meet this criterion), or, 2.7 Double barrier method of contraception consisting of spermicide with either male condom or female diaphragm.

Data type

boolean

Alias
UMLS CUI [1,1]
C1302261
UMLS CUI [1,2]
C0086287
Did the subject exhibit persistent positive symptoms in each of the 3 months prior to screening as defined by a score of 4 on at least one item of the Brief Psychiatric Rating Scale (BPRS) Psychosis score AND a total score of at least 8 on the BPRS Psychosis score, which consists of the following items: conceptual disorganizaion, hallucinatory behavior, suspiciousness and unusual thought content (items P2, P3, P6 and G9 from the PANSS)?
Description

Symptoms Positive persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0205322
Is the subject continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months with a stable dose for at least 1 month prior to entering the study?
Description

a) one to two of the following atypical antipsychotics for a minimum of 3 months prior to screening (aripiprazole, quetiapine, olanzapine, risperidone, or ziprasidone). Subjects must have adhered to a stable, optimal dose of the atypical antipsychotic(s) for at least 1 month prior to screening, OR b) clozapine, either as monotherapy or in combination with one other atypical antipsychotic, for at least 6 months prior to screening, and maintained at a constant serum level of > 350ng/ml or at a dose level of > 300mg/day of clozapine. Subjects taking clozapine must have demonstrated clinically acceptable WBC counts.

Data type

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1265611
Is the subject’s score on the CGI-S at least 4?
Description

CGI-S at least 4

Data type

boolean

Alias
UMLS CUI [1]
C3639887
Is the subject or a legal guardian able to comprehend the key components of the consent form, and able to sign and date a written informed consent form prior to the initiation of any study-related activities?
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Did the subject’s PANSS total score increase or decrease by more than 20% between the Screening and Baseline visits?
Description

Positive and negative syndrome scale Increase Percent | Positive and negative syndrome scale Decrease Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0442805
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0451383
UMLS CUI [2,2]
C0547047
UMLS CUI [2,3]
C0439165
Does the subject have a predominant (i.e., the condition that best and most completely accounts for the current presentation) Axis I disorder other than Schizophrenia within six months prior to screening?
Description

Axis I diagnosis predominant | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C1542147
UMLS CUI [2]
C0036341
Does the subject have a history of clinically significant or unstable medical disorder including, but not limited to, HIV/AIDS, hepatic, renal, respiratory, cardiovascular endocrinologic, neurologic, hematologic disease, or other disorder or treatment that would interfere with the accurate assessment of safety or efficacy, or interfere with the action, absorption, distribution, metabolism, or excretion of lamotrigine?
Description

Disease Clinical Significance Interferes with Clinical Trial | Disease Unstable Interferes with Clinical Trial | Therapeutic procedure Clinical Significance Interferes with Clinical Trial | Therapeutic procedure Unstable Interferes with Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0008976
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0008976
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C0008976
Does the subject have a history of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child) or has the subject suffered a traumatic head injury?
Description

Autistic Disorder | Pervasive Development Disorder | Organic brain disorder | Dementia | Cerebrovascular accident | Epilepsy | Seizures Requirement Therapeutic procedure | Febrile Convulsions | Craniocerebral Trauma

Data type

boolean

Alias
UMLS CUI [1]
C0004352
UMLS CUI [2]
C0524528
UMLS CUI [3]
C4062280
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0014544
UMLS CUI [7,1]
C0036572
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0087111
UMLS CUI [8]
C0009952
UMLS CUI [9]
C0018674
Does the subject have tardive dyskinesia as defined by the presence of at least moderate (AIMS = 3) abnormal movements in one or more body areas or mild (AIMS = 2) movements in at least two body areas and does the subject have Parkinson’s symptoms as defined by a score greater than 3 on Simpson-Angus, or with symptoms of akathisia greater than mild as defined by the Barnes Akathisia Scale?
Description

Unique body areas are defined as face, lips or perioral area, jaw, tongue, upper extremities, lower extremities, and trunk.

Data type

boolean

Alias
UMLS CUI [1]
C0450978
UMLS CUI [2,1]
C0030569
UMLS CUI [2,2]
C0450973
UMLS CUI [3]
C3541345
Does the subject have evidence of clinically significant abnormalities in hematology, blood chemistry, ECG or physical examination not resolved by Baseline visit?
Description

abnormal hematology, blood chemistry, ECG or physical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1332129
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C1623258
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0205161
Is the subject taking a psychotropic or primarily centrally active medication at screening except for atypical antipsychotic(s) and medications for insomnia, agitation, and extrapyramidal symptoms?
Description

Psychotropic Drugs | Central Nervous System Agents Primary

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2,1]
C0007680
UMLS CUI [2,2]
C0205225
Has the subject taken antidepressant medications or mood stabilizers within 1 month of screening?
Description

Antidepressive Agents | Mood Stabilizer

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C2917435
Is the subject taking more than two atypical antipsychotics?
Description

more than 2 atypical antipsychotics

Data type

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C1265611
Does the subject have a history of substance (which included alcohol) dependence within 12 months or abuse within 3 months of enrollment, or tested positive for an illicit drug (other than cannabinoids) on a urine analysis administered during the screening process?
Description

Subjects who tested positive for cannabinoids on the Screening urine toxicology screen test will be permitted to be randomized and continue in the study provided that in the opinion of the Investigator, the positive test outcome resulted from incidental use of the identified substance in a circumstance not associated with dependence as described in the DSM-IV-TR and which did not interfere with psychometric testing.

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0743300
Does the subject have a history of treatment with lamotrigine whereby any of the criteria in the description apply?
Description

treatment was within six months of enrollment. treatment was six or more weeks in duration. treatment resulted in intolerance. treatment resulted in an allergic or idiosyncratic reaction, including rash. treatment was administered during a clinical study

Data type

boolean

Alias
UMLS CUI [1,1]
C0064636
UMLS CUI [1,2]
C1514463
Has the subject initiated psychotherapy within 3 months prior to the screening visit, or plan to initiate psychotherapy during the trial?
Description

Psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968
Does the subject, in the investigator's judgement, pose a current homicidal or serious suicidal risk, has the subject made a suicide attempt within the six months preceding screening or has the subject ever been homicidal?
Description

Homicidal or suicidal risk

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0019872
UMLS CUI [2,2]
C1444641
Does the female subject have a positive serum HCG pregnancy test at screening visit or is lactating or planning to become pregnant within 4 months following the screening visit?
Description

Pregnancy test, planning pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1301732
Has the subject taken any other investigational medication within 30 days of screening for this study?
Description

Investigational Medication within 30 days prior to screening

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Criteria

  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia, Age
Item
Did the male or female subject age 18-65 years, inclusive, meet the diagnostic criteria for schizophrenia as defined in DSM-IV-TR?
boolean
C0036341 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Childbearing potential, Contraception
Item
Is the female eligible to enter and participate in this study?
boolean
C1302261 (UMLS CUI [1,1])
C0086287 (UMLS CUI [1,2])
Symptoms Positive persistent
Item
Did the subject exhibit persistent positive symptoms in each of the 3 months prior to screening as defined by a score of 4 on at least one item of the Brief Psychiatric Rating Scale (BPRS) Psychosis score AND a total score of at least 8 on the BPRS Psychosis score, which consists of the following items: conceptual disorganizaion, hallucinatory behavior, suspiciousness and unusual thought content (items P2, P3, P6 and G9 from the PANSS)?
boolean
C1457887 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
Atypical antipsychotic Specific Quantity
Item
Is the subject continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months with a stable dose for at least 1 month prior to entering the study?
boolean
C1276996 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
CGI-S at least 4
Item
Is the subject’s score on the CGI-S at least 4?
boolean
C3639887 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardian
Item
Is the subject or a legal guardian able to comprehend the key components of the consent form, and able to sign and date a written informed consent form prior to the initiation of any study-related activities?
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Positive and negative syndrome scale Increase Percent | Positive and negative syndrome scale Decrease Percentage
Item
Did the subject’s PANSS total score increase or decrease by more than 20% between the Screening and Baseline visits?
boolean
C0451383 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0451383 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Axis I diagnosis predominant | Schizophrenia
Item
Does the subject have a predominant (i.e., the condition that best and most completely accounts for the current presentation) Axis I disorder other than Schizophrenia within six months prior to screening?
boolean
C0270287 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
Disease Clinical Significance Interferes with Clinical Trial | Disease Unstable Interferes with Clinical Trial | Therapeutic procedure Clinical Significance Interferes with Clinical Trial | Therapeutic procedure Unstable Interferes with Clinical Trial
Item
Does the subject have a history of clinically significant or unstable medical disorder including, but not limited to, HIV/AIDS, hepatic, renal, respiratory, cardiovascular endocrinologic, neurologic, hematologic disease, or other disorder or treatment that would interfere with the accurate assessment of safety or efficacy, or interfere with the action, absorption, distribution, metabolism, or excretion of lamotrigine?
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
C0087111 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0008976 (UMLS CUI [4,4])
Autistic Disorder | Pervasive Development Disorder | Organic brain disorder | Dementia | Cerebrovascular accident | Epilepsy | Seizures Requirement Therapeutic procedure | Febrile Convulsions | Craniocerebral Trauma
Item
Does the subject have a history of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child) or has the subject suffered a traumatic head injury?
boolean
C0004352 (UMLS CUI [1])
C0524528 (UMLS CUI [2])
C4062280 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0036572 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0087111 (UMLS CUI [7,3])
C0009952 (UMLS CUI [8])
C0018674 (UMLS CUI [9])
Dyskinesia (AIMS), Parkinson's Symptoms (Simpson Angus Scale), Akathisia (Barnes Akathisia Scale)
Item
Does the subject have tardive dyskinesia as defined by the presence of at least moderate (AIMS = 3) abnormal movements in one or more body areas or mild (AIMS = 2) movements in at least two body areas and does the subject have Parkinson’s symptoms as defined by a score greater than 3 on Simpson-Angus, or with symptoms of akathisia greater than mild as defined by the Barnes Akathisia Scale?
boolean
C0450978 (UMLS CUI [1])
C0030569 (UMLS CUI [2,1])
C0450973 (UMLS CUI [2,2])
C3541345 (UMLS CUI [3])
abnormal hematology, blood chemistry, ECG or physical examination
Item
Does the subject have evidence of clinically significant abnormalities in hematology, blood chemistry, ECG or physical examination not resolved by Baseline visit?
boolean
C1332129 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
Psychotropic Drugs | Central Nervous System Agents Primary
Item
Is the subject taking a psychotropic or primarily centrally active medication at screening except for atypical antipsychotic(s) and medications for insomnia, agitation, and extrapyramidal symptoms?
boolean
C0033978 (UMLS CUI [1])
C0007680 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Antidepressive Agents | Mood Stabilizer
Item
Has the subject taken antidepressant medications or mood stabilizers within 1 month of screening?
boolean
C0003289 (UMLS CUI [1])
C2917435 (UMLS CUI [2])
more than 2 atypical antipsychotics
Item
Is the subject taking more than two atypical antipsychotics?
boolean
C1276996 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Substance dependence, positive drug screen
Item
Does the subject have a history of substance (which included alcohol) dependence within 12 months or abuse within 3 months of enrollment, or tested positive for an illicit drug (other than cannabinoids) on a urine analysis administered during the screening process?
boolean
C0038580 (UMLS CUI [1])
C0743300 (UMLS CUI [2])
Prior Treatment with Lamotrigine
Item
Does the subject have a history of treatment with lamotrigine whereby any of the criteria in the description apply?
boolean
C0064636 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Psychotherapy
Item
Has the subject initiated psychotherapy within 3 months prior to the screening visit, or plan to initiate psychotherapy during the trial?
boolean
C0033968 (UMLS CUI [1])
Homicidal or suicidal risk
Item
Does the subject, in the investigator's judgement, pose a current homicidal or serious suicidal risk, has the subject made a suicide attempt within the six months preceding screening or has the subject ever been homicidal?
boolean
C0563664 (UMLS CUI [1])
C0019872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
Pregnancy test, planning pregnancy
Item
Does the female subject have a positive serum HCG pregnancy test at screening visit or is lactating or planning to become pregnant within 4 months following the screening visit?
boolean
C0240802 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Investigational Medication within 30 days prior to screening
Item
Has the subject taken any other investigational medication within 30 days of screening for this study?
boolean
C2348568 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial