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Investigating the effect of prampixol on major depression in patients treated with buprenorphine

Investigating the effectiveness of pramipexole on anhedonia in patients undergoing maintenance therapy by buprenorphine: randomized double blind placebo: controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240905062953N1
Enrollment
30
Registered
2024-10-10
Start date
2024-11-05
Completion date
Unknown
Last updated
2025-01-08

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, severe without psychotic features

Interventions

Intervention 1: Intervention group (pramipexole): Pramipexole tablets start with a dose of 0.375 mg and if drug tolerance is increased to 0.75 mg in the second week and to 1.5 mg in the third week and

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: The age of patients is more than 18 years and less than 75 years undergoing psychotherapy during the study period Patients with unipolar depression or bipolar patients in the phase of depression or dysthymia Clinical symptoms of anhedonia with a score of 3 or 4 in at least 3 items of the SHAPS questionnaire Patients treated with buprenorphine for at least 4 weeks

Exclusion criteria

Exclusion criteria: History of severe allergic reaction to pramipexole drug or intolerable drug side effects Associated diseases such as hepatitis B and C and liver and kidney failure, uncontrolled thyroid disease, neurological disease, severe asthma and intestinal obstruction. Moderate to severe mental retardation Patients with known and treated dementia Patients with psychotic symptoms breastfeeding Patients needing hospitalization or treatment with ECT according to the psychiatrist's opinion Pregnant women or women who plan to become pregnant in the next few months Presence of suicidal thoughts Simultaneous consumption of psychedelic and hallucinogenic substances Taking drugs that have a significant interaction with Pramipexol, including drugs that cause QT interval prolongation.

Design outcomes

Primary

MeasureTime frame
Anhedonia. Timepoint: At entry into the study, week 4 and week 8. Method of measurement: Dimensional anhedonia rating scale(DARS).;Quality of life. Timepoint: At entry into the study, week 4 and week 8. Method of measurement: WHO-QOL-BRE.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoma Bagheian

Kerman University of Medical Sciences

homabagherianid@gmail.com+98 34 3211 1398

Outcome results

None listed

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