Adalimumab as a adjuvant therapy in modrate to sever MDD

Adalimumab as a adjuvant therapy in modrate to sever MDD in patients with CRP greater than or equal to 3mgr/lit : a double blind and randomized Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090117001556N121

Enrollment

Registered

2019-10-19

Start date

2019-11-21

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder. Major depressive disorder, single episode, moderate

Interventions

Intervention 1: Intervention group: Adalimumab(iv) 5 mg/kg at the beginning plus tablet sertralin up to100 mg/day for 6 weeks. Intervention 2: Control group: placebo(iv) at the begenning plus tablet

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Severity of depression. Timepoint: Baseline and weeks 2,4 and 6. Method of measurement: By Hamiltion Depression Rating Scale 17-Item.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026