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Adalimumab as a adjuvant therapy in modrate to sever MDD

Phase 3
Conditions
Major Depressive Disorder.
Major depressive disorder, single episode, moderate
F32.1
Registration Number
IRCT20090117001556N121
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
50
Inclusion Criteria

Presence of Major Depressive Disorder based on DSM-5 criteria
Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 19
CRP equals or more than 3mg/lit

Exclusion Criteria

Psychotic symptoms
Any other mental disorder
Hypothyroidism
Cardiovascular disease
Pregnant or nursing women
History of tuberculosis
Autoimmune disease
Viral hepatitis
Chronic or recurrent infections
Receiving ECT during the last two months
Significant suicidal ideation
Substance use
HIV

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of depression. Timepoint: Baseline and weeks 2,4 and 6. Method of measurement: By Hamiltion Depression Rating Scale 17-Item.
Secondary Outcome Measures
NameTimeMethod
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