Effects of alkaloids of harmala seeds on depressio

Phase 2

• Conditions: Depression.; Major depressive disorder, recurrent, moderate; F33.1

• Registration Number: IRCT20170311033004N3
• Lead Sponsor: Iranian academic center for education culture and research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

ability to read, understating and sign the informed consent form and the study procedures
male or female aged 18–65 years without any previous diagnosis of other mental disorders such as bipolar disorder, psychosis, primary anxiety disorder, and substance abuse or dependence disorder
reporting the Hamilton Depression Rating Score (HAMD) score above 14
agreed to use suitable family planning methods during the study and three months afterward
non-smoking
not being pregnant
under only SSRIs antidepressant regimen

Exclusion Criteria

they have a current diagnosis of other mental disorders including bipolar disorder, psychosis, primary anxiety disorder, and substance abuse or dependence disorder
pregnancy and breastfeeding
taking antidepressant except for SSRIs, mood stabilizer, or antipsychotic drug
chemotherapy or other medications known to produce mood changes
sensitivity to harmala alkaloids
emerging serious adverse effects with the alkaloids

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anhedonia, depressed mood, change in appetite, sleep, and suicidal ideations. Timepoint: Week 0, 4 and 6. Method of measurement: Hamilton Depression Rating Scale score.;Depression. Timepoint: Week 0, 4 and 6. Method of measurement: Beck Depression Inventory.