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Effects of alkaloids of harmala seeds on depression

Evaluation of adjunctive therapy of seeds alkaloids of Peganum harmala in the treatment of mild to moderate depression

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170311033004N3
Enrollment
68
Registered
2022-02-01
Start date
2022-04-03
Completion date
Unknown
Last updated
2022-02-07

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

Conditions

Depression. Major depressive disorder, recurrent, moderate

Interventions

Intervention 1: Intervention group: harmala alkaloids: Extraction is performed through routine methods for alkaloids extraction. Then a semi-automatic capsule filler was used to fill the harmaline cap

Sponsors

Iranian academic center for education culture and research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Razmi

Iranian academic center for education culture and research

arazmi@alumnus.tums.ac.ir+98 26 3476 4010

Outcome results

None listed

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