Adalimumab as a adjuvant therapy in modrate to sever MDD
Phase 3
- Conditions
- Major Depressive Disorder.Major depressive disorder, single episode, moderateF32.1
- 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
Name Time Method Severity of depression. Timepoint: Baseline and weeks 2,4 and 6. Method of measurement: By Hamiltion Depression Rating Scale 17-Item.
- Secondary Outcome Measures
Name Time Method