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Efficacy and Safety of Pramipexole as an augmenting agent for Major Depressive Disorder.

Efficacy and Safety of Pramipexole as an augmenting agent for Major Depressive Disorder- A Pragmatic Trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078604
Enrollment
70
Registered
2024-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features

Interventions

Intervention1: SSRIs plus Pramipexole: (0.375mg/day starting dose and maximaly titrated ot 4.5mg/day based on tolerability and clinical assessments over 8 weeks Control Intervention1: SSRI + placebo:

Sponsors

Dr Vincent Soram
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Major depressive disorder as diagnosed by DSM-5 criteria Presence of clinically assessed motivational deficits, psychomotor retardation and anhedonia score less than 30 on Dimensional Anhedonia Rating Scale

Exclusion criteria

Exclusion criteria: Comorbid psychotic spectrum, bipolar or severe personality disorders Concurrent dopamine antagonists or agonist therapy Current substance withdrawal or intoxicated states Pregnancy, lactation or inadequate contraception among women Parkinsons disease

Design outcomes

Primary

MeasureTime frame
Decrease in the score of Montgomery–Åsberg Depression Rating Scale over 4 weeksTimepoint: Decrease in the score of Montgomery–Åsberg Depression Rating Scale over 4 weeks

Secondary

MeasureTime frame
Change in score of Clinical Global Impression Scale over 4 weeks.Timepoint: Change in score of Clinical Global Impression Scale over 4 weeks.;Change in score of Dimensional Anhedonia rating scale over 4 weeks Timepoint: Change in score of Dimensional Anhedonia rating scale over 4 weeks

Countries

India

Contacts

Public ContactDr Vincent Soram

Kalinga Institute of Medical Sciences

linksudipta@gmail.com6009296843

Outcome results

None listed

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