Theanine as an adjuvant therapy in the treatment of major depressive disorder
Phase 2
- Conditions
- Major Depressive Disorder.Major depressive disorder, single episode, severe without psychotic featuresF32.2
- Registration Number
- IRCT20090117001556N131
- 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
Diagnosis of major depressive disorder, based on DSM-5
Age between 18 to 60 years
The minimum score of 19, based on Hamilton depression scale
Exclusion Criteria
Drug use during 1 year prior to trial (except nicotine)
Receive psychotropic drugs during 1 month prior to trial
History of Electroconvulsive therapy, two months prior to the trial
Psychosis
History of at least one period of mania or hypomania or mixed
Serious suicidal thoughts (The score of >2 in Hamilton depression scale, the suicidal tendencies section)
Kidney, liver, cardiovascular, or thyroid disorders
Pregnant or lactating women
Presence of concomitant psychiatric disorders
The patient's own request to leave the study
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 Hamilton depression scale.
- Secondary Outcome Measures
Name Time Method