ID

30434

Description

A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00675896

Link

https://clinicaltrials.gov/show/NCT00675896

Keywords

Versions (1)
  1. 6/5/18 6/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depression NCT00675896

English

Eligibility Major Depression NCT00675896

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a dsm iv diagnosis of major depression and fibromyalgia confirmed by using the american college of rheumatology criteria. male or female between the ages of 18 and 65.
Description

Major Depressive Disorder | Fibromyalgia | Age

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0016053
UMLS CUI [3]
C0001779
patients who score at least 22 on the 17-item ham-d scale and at least 4 (i.e., moderately ill) on the clinical global impression (cgi) severity scale. both criteria have to be met at screening and baseline (study day 0).
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification | Clinical global impression scale

Data type

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C3639708
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with dsm-iv axis 1 disorder other than mdd and chronic pain disorder within 6 months of enrolment.
Description

Axis I diagnosis | Exception Major Depressive Disorder | Chronic pain syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
UMLS CUI [3]
C1298685
history of inadequate response to adequate treatment (6 weeks) with 2 or more classes of antidepressants during current depressive episode.
Description

Antidepressive Agents Class Quantity Depressive episode | Response Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0349217
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
patients who, in the investigator's opinion, pose a risk for suicide.
Description

At risk for suicide

Data type

boolean

Alias
UMLS CUI [1]
C0563664
history of suicide attempt within 3 years of entering study.
Description

Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C0038663
current depressive episode secondary to general medical condition excluding fibromyalgia.
Description

Depressive episode Secondary to Medical condition General | Fibromyalgia Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C3843040
UMLS CUI [1,4]
C0205246
UMLS CUI [2,1]
C0016053
UMLS CUI [2,2]
C0332196
history or presence of bipolar disorder or psychosis.
Description

Bipolar Disorder | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0033975
post traumatic stress disorder, anorexia nervosa or bulimia nervosa.
Description

Post-Traumatic Stress Disorder | Anorexia Nervosa | Bulimia Nervosa

Data type

boolean

Alias
UMLS CUI [1]
C0038436
UMLS CUI [2]
C0003125
UMLS CUI [3]
C2267227
patients with diagnosis of dsm-iv axis ii disorder which has a major impact on the patient's current psychiatric status.
Description

Axis II diagnosis Impact Status Psychiatric

Data type

boolean

Alias
UMLS CUI [1,1]
C0270288
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C0205487
present dsm iv diagnosis of substance abuse or dependence within 6 months prior of the screening visit (except dependence in full remission, and except caffeine, nicotine or opiate dependence)
Description

Substance Use Disorders | Substance Dependence | Exception Dependence Remission | Exception Caffeine dependence | Exception Nicotine Dependence | Exception Opiate Addiction

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038580
UMLS CUI [3,3]
C0544452
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1386553
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0028043
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0524662
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Similar models

Eligibility Major Depression NCT00675896

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Fibromyalgia | Age
Item
patients with a dsm iv diagnosis of major depression and fibromyalgia confirmed by using the american college of rheumatology criteria. male or female between the ages of 18 and 65.
boolean
C1269683 (UMLS CUI [1])
C0016053 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Clinical global impression scale
Item
patients who score at least 22 on the 17-item ham-d scale and at least 4 (i.e., moderately ill) on the clinical global impression (cgi) severity scale. both criteria have to be met at screening and baseline (study day 0).
boolean
C3639712 (UMLS CUI [1])
C3639708 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Exception Major Depressive Disorder | Chronic pain syndrome
Item
patients with dsm-iv axis 1 disorder other than mdd and chronic pain disorder within 6 months of enrolment.
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
C1298685 (UMLS CUI [3])
Antidepressive Agents Class Quantity Depressive episode | Response Inadequate
Item
history of inadequate response to adequate treatment (6 weeks) with 2 or more classes of antidepressants during current depressive episode.
boolean
C0003289 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0349217 (UMLS CUI [1,4])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
At risk for suicide
Item
patients who, in the investigator's opinion, pose a risk for suicide.
boolean
C0563664 (UMLS CUI [1])
Suicide attempt
Item
history of suicide attempt within 3 years of entering study.
boolean
C0038663 (UMLS CUI [1])
Depressive episode Secondary to Medical condition General | Fibromyalgia Excluded
Item
current depressive episode secondary to general medical condition excluding fibromyalgia.
boolean
C0349217 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
C0205246 (UMLS CUI [1,4])
C0016053 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Bipolar Disorder | Psychotic Disorders
Item
history or presence of bipolar disorder or psychosis.
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Post-Traumatic Stress Disorder | Anorexia Nervosa | Bulimia Nervosa
Item
post traumatic stress disorder, anorexia nervosa or bulimia nervosa.
boolean
C0038436 (UMLS CUI [1])
C0003125 (UMLS CUI [2])
C2267227 (UMLS CUI [3])
Axis II diagnosis Impact Status Psychiatric
Item
patients with diagnosis of dsm-iv axis ii disorder which has a major impact on the patient's current psychiatric status.
boolean
C0270288 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205487 (UMLS CUI [1,4])
Substance Use Disorders | Substance Dependence | Exception Dependence Remission | Exception Caffeine dependence | Exception Nicotine Dependence | Exception Opiate Addiction
Item
present dsm iv diagnosis of substance abuse or dependence within 6 months prior of the screening visit (except dependence in full remission, and except caffeine, nicotine or opiate dependence)
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0038580 (UMLS CUI [3,2])
C0544452 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1386553 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0028043 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0524662 (UMLS CUI [6,2])
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