ID

30482

Beskrivning

Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs; ODM derived from: https://clinicaltrials.gov/show/NCT00633399

Länk

https://clinicaltrials.gov/show/NCT00633399

Nyckelord

Versioner (1)
  1. 2018-06-08 2018-06-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00633399

Engelsk

Eligibility Major Depressive Disorder NCT00633399

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
men or women, 18-65 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
mdd, current, according to dsm-iv criteria and as diagnosed by the scid- i/p during the screen and baseline visit of phase 1.
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
a ham-d-17 score > 14 during the screen and baseline visit of phase 1.
Beskrivning

Hamilton Depression Rating Scale 17 Item Clinical Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine
Beskrivning

Pregnancy | Childbearing Potential Contraceptive methods Absent | Oral contraception | Contraceptive implant | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0029151
UMLS CUI [4]
C1657106
UMLS CUI [5]
C0221829
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0021900
device, tubal ligation, or partner with vasectomy).
Beskrivning

Tubal Ligation | Partner had vasectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0520483
UMLS CUI [2]
C0420842
serious suicide or homicide risk, as assessed by evaluating clinician.
Beskrivning

At risk for suicide Serious | Homicide At risk Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0019872
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0205404
unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
Beskrivning

Illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | Nervous system disorder | Hematological Disease | Epilepsy Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0018939
UMLS CUI [9,1]
C0014544
UMLS CUI [9,2]
C0205318
history of multiple adverse drug reactions or allergy to the study drug.
Beskrivning

Adverse reaction to drug Multiple | Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0439064
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
the following dsm-iv diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past).
Beskrivning

Substance Use Disorders | Bipolar Disorder | Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0033975
patients requiring excluded medications (see appendix 1 for details).
Beskrivning

Patient need for Pharmaceutical Preparations Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332196
psychotic features in the current episode or a history of psychotic features.
Beskrivning

Feature Psychotic Depressive episode | Feature Psychotic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348519
UMLS CUI [1,2]
C0033975
UMLS CUI [1,3]
C0349217
UMLS CUI [2,1]
C2348519
UMLS CUI [2,2]
C0033975
prior course of ziprasidone, or intolerance to ziprasidone at any dose.
Beskrivning

Ziprasidone | Intolerance to Ziprasidone Dose Any

Datatyp

boolean

Alias
UMLS CUI [1]
C0380393
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0380393
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1552551
any investigational psychotropic drug within the last 3 months.
Beskrivning

Psychotropic Drug Investigational

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C1517586
have failed more than 3 adequate antidepressant trials during the current mde. some examples of adequate dosage of an antidepressant trial include either > 150 mg of imipramine (or its tricyclic equivalent), > 60 mg of phenelzine (or its monoamine oxidase inhibitor equivalent), > 20 mg of fluoxetine (or its ssri-equivalent), > 150mg of bupropion, > 300mg of trazodone (or nefazodone), >75 mg of venlafaxine, >60mg of duloxetine, or > 15mg of mirtazapine. a trial of adequate duration was defined as one during which the patient was on any given antidepressant at an adequate dose for a minimum of 6 weeks.
Beskrivning

Major depressive episode | Antidepressive Agents | Therapeutic procedure Quantity | Imipramine Dosage | Tricyclic Antidepressive Agents Equivalent | Phenelzine Dosage | Monoamine Oxidase Inhibitors Equivalent | Fluoxetine Dosage | Selective Serotonin Reuptake Inhibitors Equivalent | Bupropion Dosage | Trazodone Dosage | Nefazodone Dosage | Venlafaxine Dosage | Duloxetine Dosage | Mirtazapine Dosage

Datatyp

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0003289
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0020934
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0003290
UMLS CUI [5,2]
C0205163
UMLS CUI [6,1]
C0031392
UMLS CUI [6,2]
C0178602
UMLS CUI [7,1]
C0026457
UMLS CUI [7,2]
C0205163
UMLS CUI [8,1]
C0016365
UMLS CUI [8,2]
C0178602
UMLS CUI [9,1]
C0360105
UMLS CUI [9,2]
C0205163
UMLS CUI [10,1]
C0085208
UMLS CUI [10,2]
C0178602
UMLS CUI [11,1]
C0040805
UMLS CUI [11,2]
C0178602
UMLS CUI [12,1]
C0068485
UMLS CUI [12,2]
C0178602
UMLS CUI [13,1]
C0078569
UMLS CUI [13,2]
C0178602
UMLS CUI [14,1]
C0245561
UMLS CUI [14,2]
C0178602
UMLS CUI [15,1]
C0049506
UMLS CUI [15,2]
C0178602
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Similar models

Eligibility Major Depressive Disorder NCT00633399

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
men or women, 18-65 years of age.
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
mdd, current, according to dsm-iv criteria and as diagnosed by the scid- i/p during the screen and baseline visit of phase 1.
boolean
C1269683 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
a ham-d-17 score > 14 during the screen and baseline visit of phase 1.
boolean
C3639712 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods Absent | Oral contraception | Contraceptive implant | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices
Item
pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0029151 (UMLS CUI [3])
C1657106 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
Tubal Ligation | Partner had vasectomy
Item
device, tubal ligation, or partner with vasectomy).
boolean
C0520483 (UMLS CUI [1])
C0420842 (UMLS CUI [2])
At risk for suicide Serious | Homicide At risk Serious
Item
serious suicide or homicide risk, as assessed by evaluating clinician.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | Nervous system disorder | Hematological Disease | Epilepsy Uncontrolled
Item
unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
C0014544 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
Adverse reaction to drug Multiple | Hypersensitivity Investigational New Drugs
Item
history of multiple adverse drug reactions or allergy to the study drug.
boolean
C0041755 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Substance Use Disorders | Bipolar Disorder | Psychotic Disorders
Item
the following dsm-iv diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past).
boolean
C0038586 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
Patient need for Pharmaceutical Preparations Excluded
Item
patients requiring excluded medications (see appendix 1 for details).
boolean
C0686904 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Feature Psychotic Depressive episode | Feature Psychotic
Item
psychotic features in the current episode or a history of psychotic features.
boolean
C2348519 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0349217 (UMLS CUI [1,3])
C2348519 (UMLS CUI [2,1])
C0033975 (UMLS CUI [2,2])
Ziprasidone | Intolerance to Ziprasidone Dose Any
Item
prior course of ziprasidone, or intolerance to ziprasidone at any dose.
boolean
C0380393 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0380393 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1552551 (UMLS CUI [2,4])
Psychotropic Drug Investigational
Item
any investigational psychotropic drug within the last 3 months.
boolean
C0033978 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Major depressive episode | Antidepressive Agents | Therapeutic procedure Quantity | Imipramine Dosage | Tricyclic Antidepressive Agents Equivalent | Phenelzine Dosage | Monoamine Oxidase Inhibitors Equivalent | Fluoxetine Dosage | Selective Serotonin Reuptake Inhibitors Equivalent | Bupropion Dosage | Trazodone Dosage | Nefazodone Dosage | Venlafaxine Dosage | Duloxetine Dosage | Mirtazapine Dosage
Item
have failed more than 3 adequate antidepressant trials during the current mde. some examples of adequate dosage of an antidepressant trial include either > 150 mg of imipramine (or its tricyclic equivalent), > 60 mg of phenelzine (or its monoamine oxidase inhibitor equivalent), > 20 mg of fluoxetine (or its ssri-equivalent), > 150mg of bupropion, > 300mg of trazodone (or nefazodone), >75 mg of venlafaxine, >60mg of duloxetine, or > 15mg of mirtazapine. a trial of adequate duration was defined as one during which the patient was on any given antidepressant at an adequate dose for a minimum of 6 weeks.
boolean
C0024517 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0020934 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0003290 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0031392 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0026457 (UMLS CUI [7,1])
C0205163 (UMLS CUI [7,2])
C0016365 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0360105 (UMLS CUI [9,1])
C0205163 (UMLS CUI [9,2])
C0085208 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0040805 (UMLS CUI [11,1])
C0178602 (UMLS CUI [11,2])
C0068485 (UMLS CUI [12,1])
C0178602 (UMLS CUI [12,2])
C0078569 (UMLS CUI [13,1])
C0178602 (UMLS CUI [13,2])
C0245561 (UMLS CUI [14,1])
C0178602 (UMLS CUI [14,2])
C0049506 (UMLS CUI [15,1])
C0178602 (UMLS CUI [15,2])
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