ID

30511

Description

N-methylglycine (Sarcosine) Treatment for Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00977353

Lien

https://clinicaltrials.gov/show/NCT00977353

Mots-clés

Versions (1)
  1. 10/06/2018 10/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

10 juin 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00977353

Anglais

Eligibility Major Depressive Disorder NCT00977353

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18-55 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
fulfilled the dsm-iv criteria of major depressive disorder
Description

Major Depressive Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C1269683
had a 17-item hamilton rating scale for depression (hamd-17)>or= 18
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification

Type de données

boolean

Alias
UMLS CUI [1]
C3639712
no dsm-iv diagnosis of substance abuse or dependence (including alcohol) within the past 6 months
Description

Substance Use Disorders Absent | Substance Dependence Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0332197
had been drug free for > 3 months
Description

Drugs Free of

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332296
physically healthy and had all laboratory parameters within normal limits.
Description

Healthy Physical | Laboratory Results Within Normal Limits

Type de données

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0205485
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0442816
agree to participate in the study and provide informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
had history of epilepsy, head trauma or other major neurological or medical diseases
Description

Epilepsy | Craniocerebral Trauma | Nervous system disorde Major | Disease Major

Type de données

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0018674
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205164
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205164
had psychotic depression, bipolar i/ii disorder, schizophrenia or any other psychotic disorder
Description

Depression, psychotic | Bipolar I disorder | Bipolar II disorder | Schizophrenia | Psychotic Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0743072
UMLS CUI [2]
C0853193
UMLS CUI [3]
C0236788
UMLS CUI [4]
C0036341
UMLS CUI [5]
C0033975
moderate-severe suicidal risks
Description

Moderate suicide risk | At risk for suicide Severe

Type de données

boolean

Alias
UMLS CUI [1]
C1271075
UMLS CUI [2,1]
C0563664
UMLS CUI [2,2]
C0205082
severe cognitive impairment
Description

Severe cognitive impairment

Type de données

boolean

Alias
UMLS CUI [1]
C3554639
female subjects who were pregnant, or at risk of pregnancy or lactation
Description

Pregnancy | At risk Pregnancy | At risk Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0032961
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0006147
initiating or stopping formal psychotherapy within six weeks prior to enrollment
Description

Psychotherapy Initiation | Psychotherapy Discontinuation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C1704686
UMLS CUI [2,1]
C0033968
UMLS CUI [2,2]
C1444662
had a history of poor response to ssris or previously received electroconvulsive therapy
Description

Poor response to Selective Serotonin Reuptake Inhibitors | Electroconvulsive Therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1320680
UMLS CUI [1,2]
C0360105
UMLS CUI [2]
C0013806
had a history of severe adverse reaction to ssris.
Description

Adverse reaction Severe Selective Serotonin Reuptake Inhibitors

Type de données

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0360105
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Similar models

Eligibility Major Depressive Disorder NCT00977353

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 18-55 years
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
fulfilled the dsm-iv criteria of major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
had a 17-item hamilton rating scale for depression (hamd-17)>or= 18
boolean
C3639712 (UMLS CUI [1])
Substance Use Disorders Absent | Substance Dependence Absent
Item
no dsm-iv diagnosis of substance abuse or dependence (including alcohol) within the past 6 months
boolean
C0038586 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Drugs Free of
Item
had been drug free for > 3 months
boolean
C0013227 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Healthy Physical | Laboratory Results Within Normal Limits
Item
physically healthy and had all laboratory parameters within normal limits.
boolean
C3898900 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C1254595 (UMLS CUI [2,1])
C0442816 (UMLS CUI [2,2])
Informed Consent
Item
agree to participate in the study and provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Epilepsy | Craniocerebral Trauma | Nervous system disorde Major | Disease Major
Item
had history of epilepsy, head trauma or other major neurological or medical diseases
boolean
C0014544 (UMLS CUI [1])
C0018674 (UMLS CUI [2])
C0027765 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
Depression, psychotic | Bipolar I disorder | Bipolar II disorder | Schizophrenia | Psychotic Disorders
Item
had psychotic depression, bipolar i/ii disorder, schizophrenia or any other psychotic disorder
boolean
C0743072 (UMLS CUI [1])
C0853193 (UMLS CUI [2])
C0236788 (UMLS CUI [3])
C0036341 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
Moderate suicide risk | At risk for suicide Severe
Item
moderate-severe suicidal risks
boolean
C1271075 (UMLS CUI [1])
C0563664 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Severe cognitive impairment
Item
severe cognitive impairment
boolean
C3554639 (UMLS CUI [1])
Pregnancy | At risk Pregnancy | At risk Breast Feeding
Item
female subjects who were pregnant, or at risk of pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C1444641 (UMLS CUI [3,1])
C0006147 (UMLS CUI [3,2])
Psychotherapy Initiation | Psychotherapy Discontinuation
Item
initiating or stopping formal psychotherapy within six weeks prior to enrollment
boolean
C0033968 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0033968 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Poor response to Selective Serotonin Reuptake Inhibitors | Electroconvulsive Therapy
Item
had a history of poor response to ssris or previously received electroconvulsive therapy
boolean
C1320680 (UMLS CUI [1,1])
C0360105 (UMLS CUI [1,2])
C0013806 (UMLS CUI [2])
Adverse reaction Severe Selective Serotonin Reuptake Inhibitors
Item
had a history of severe adverse reaction to ssris.
boolean
C0559546 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0360105 (UMLS CUI [1,3])
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