ID

30527

Description

Effect of Curcumin as Nutraceutical in Patients of Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01022632

Link

https://clinicaltrials.gov/show/NCT01022632

Keywords

Versions (1)
  1. 6/11/18 6/11/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 11, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01022632

English

Eligibility Major Depressive Disorder NCT01022632

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
depression as diagnosed under dsm-iv axis i disorders.
Description

Depressive disorder | Axis I diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0270287
score greater than 7 but less then 35 on the 17-item hamilton depression (ham-d) scale at screening.
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C3639712
the patient has relative(s) to care for him/her
Description

Availability of Relative Patient care

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0080103
UMLS CUI [1,3]
C0017313
informed consent obtained from the patient or relative
Description

Informed Consent | Informed Consent Relative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0080103
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
scores greater than 2 on the "suicide" item of ham-d, or history of suicide attempt(s) in the past 12 months.
Description

Hamilton rating scale for depression | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C0451203
UMLS CUI [2]
C0038663
current suicidal or homicidal risk, as determined by the investigator.
Description

At risk for suicide | At risk Homicide

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0019872
clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal.
Description

Liver diseases | Hepatitis | Liver Cirrhosis | Elevated liver enzymes

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0023890
UMLS CUI [4]
C0235996
history of seizure disorder (other than febrile).
Description

Epilepsy | Exception Febrile seizure

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0009952
patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days
Description

Monoamine Oxidase Inhibitors | Selective Serotonin Reuptake Inhibitors | Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0360105
UMLS CUI [3]
C0003289
any of the following dsm-iv diagnoses current (within past 3 months) schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent)
Description

Schizophrenia | Schizoaffective Disorder | Psychotic Disorders | Bipolar Disorder | Panic Disorder | Obsessive-Compulsive Disorder | Afffective Disorders Feature Psychotic | Mood Congruent | Mood Incongruent

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0030319
UMLS CUI [6]
C0028768
UMLS CUI [7,1]
C0525045
UMLS CUI [7,2]
C2348519
UMLS CUI [7,3]
C0033975
UMLS CUI [8,1]
C0026516
UMLS CUI [8,2]
C0439853
UMLS CUI [9,1]
C0026516
UMLS CUI [9,2]
C1321310
patient with history of untreated or unstable thyroid disorder
Description

Thyroid Disease untreated | Thyroid Disease Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C0443343
failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or maoi equivalent, or greater than or equal to 100 mg of sertraline, or its ssri equivalent.
Description

Antidepressant therapy Quantity | Response failed | Imipramine Dosage | Tricyclic Antidepressive Agents Equivalent | Phenelzine Dosage | Monoamine Oxidase Inhibitors Equivalent | Sertraline Dosage | Selective Serotonin Reuptake Inhibitors Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0020934
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0003290
UMLS CUI [4,2]
C0205163
UMLS CUI [5,1]
C0031392
UMLS CUI [5,2]
C0178602
UMLS CUI [6,1]
C0026457
UMLS CUI [6,2]
C0205163
UMLS CUI [7,1]
C0074393
UMLS CUI [7,2]
C0178602
UMLS CUI [8,1]
C0360105
UMLS CUI [8,2]
C0205163
have had other investigational drugs within 30 days or other psychotropic medication within 21 days.
Description

Investigational New Drugs | Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0033978
known allergy or hypersensitivity to the study medications.
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
receiving psychotherapies which are specifically designed to treat depression, eg, interpersonal psychotherapy during the study period.
Description

Psychotherapy Specific Depressive disorder | Interpersonal psychotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0011581
UMLS CUI [2]
C0871787
mental retardation or cognitive impairment, or any disorder that might interfere with their ability to give consent or follow study procedures and requirements.
Description

Mental Retardation | Impaired cognition | Disease Interferes with Informed Consent | Disease Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0338656
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
in case of female patients, abstinence or effective method of contraception throughout the study
Description

Gender Sexual Abstinence | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
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Similar models

Eligibility Major Depressive Disorder NCT01022632

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Depressive disorder | Axis I diagnosis
Item
depression as diagnosed under dsm-iv axis i disorders.
boolean
C0011581 (UMLS CUI [1])
C0270287 (UMLS CUI [2])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
score greater than 7 but less then 35 on the 17-item hamilton depression (ham-d) scale at screening.
boolean
C3639712 (UMLS CUI [1])
Availability of Relative Patient care
Item
the patient has relative(s) to care for him/her
boolean
C0470187 (UMLS CUI [1,1])
C0080103 (UMLS CUI [1,2])
C0017313 (UMLS CUI [1,3])
Informed Consent | Informed Consent Relative
Item
informed consent obtained from the patient or relative
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0080103 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hamilton rating scale for depression | Suicide attempt
Item
scores greater than 2 on the "suicide" item of ham-d, or history of suicide attempt(s) in the past 12 months.
boolean
C0451203 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
At risk for suicide | At risk Homicide
Item
current suicidal or homicidal risk, as determined by the investigator.
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0019872 (UMLS CUI [2,2])
Liver diseases | Hepatitis | Liver Cirrhosis | Elevated liver enzymes
Item
clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal.
boolean
C0023895 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0235996 (UMLS CUI [4])
Epilepsy | Exception Febrile seizure
Item
history of seizure disorder (other than febrile).
boolean
C0014544 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0009952 (UMLS CUI [2,2])
Monoamine Oxidase Inhibitors | Selective Serotonin Reuptake Inhibitors | Antidepressive Agents
Item
patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days
boolean
C0026457 (UMLS CUI [1])
C0360105 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
Schizophrenia | Schizoaffective Disorder | Psychotic Disorders | Bipolar Disorder | Panic Disorder | Obsessive-Compulsive Disorder | Afffective Disorders Feature Psychotic | Mood Congruent | Mood Incongruent
Item
any of the following dsm-iv diagnoses current (within past 3 months) schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent)
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0030319 (UMLS CUI [5])
C0028768 (UMLS CUI [6])
C0525045 (UMLS CUI [7,1])
C2348519 (UMLS CUI [7,2])
C0033975 (UMLS CUI [7,3])
C0026516 (UMLS CUI [8,1])
C0439853 (UMLS CUI [8,2])
C0026516 (UMLS CUI [9,1])
C1321310 (UMLS CUI [9,2])
Thyroid Disease untreated | Thyroid Disease Unstable
Item
patient with history of untreated or unstable thyroid disorder
boolean
C0040128 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0040128 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Antidepressant therapy Quantity | Response failed | Imipramine Dosage | Tricyclic Antidepressive Agents Equivalent | Phenelzine Dosage | Monoamine Oxidase Inhibitors Equivalent | Sertraline Dosage | Selective Serotonin Reuptake Inhibitors Equivalent
Item
failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or maoi equivalent, or greater than or equal to 100 mg of sertraline, or its ssri equivalent.
boolean
C1096649 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0020934 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0003290 (UMLS CUI [4,1])
C0205163 (UMLS CUI [4,2])
C0031392 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0026457 (UMLS CUI [6,1])
C0205163 (UMLS CUI [6,2])
C0074393 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0360105 (UMLS CUI [8,1])
C0205163 (UMLS CUI [8,2])
Investigational New Drugs | Psychotropic Drugs
Item
have had other investigational drugs within 30 days or other psychotropic medication within 21 days.
boolean
C0013230 (UMLS CUI [1])
C0033978 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs
Item
known allergy or hypersensitivity to the study medications.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Psychotherapy Specific Depressive disorder | Interpersonal psychotherapy
Item
receiving psychotherapies which are specifically designed to treat depression, eg, interpersonal psychotherapy during the study period.
boolean
C0033968 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0011581 (UMLS CUI [1,3])
C0871787 (UMLS CUI [2])
Mental Retardation | Impaired cognition | Disease Interferes with Informed Consent | Disease Interferes with Protocol Compliance
Item
mental retardation or cognitive impairment, or any disorder that might interfere with their ability to give consent or follow study procedures and requirements.
boolean
C0025362 (UMLS CUI [1])
C0338656 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Gender Sexual Abstinence | Gender Contraceptive methods
Item
in case of female patients, abstinence or effective method of contraception throughout the study
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
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