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Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511085-37-00
Acronym
OCD-RT
Enrollment
48
Registered
2024-05-21
Start date
2024-08-19
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Obsessive-compulsive disorder (OCD)

Brief summary

Difference in the total score of the Y-BOCS scale between baseline (V1; before intervention with the investigational drug) and week 16 (V9; after intervention with the investigational drug), between the different groups treated with different doses of pramipexole.

Detailed description

Number of adverse events observed (nonserious, serious not related to the investigational medicinal product, and serious related to the investigational medicinal product) from day 2 (V1; after the first dose of the investigational medicinal product) to the week 24 (V11; end of study) in the different pramipexole treatment groups.

Interventions

DRUGPramipexol Aurobindo 0
DRUG35 mg tabletter
DRUG18 mg tabletter

Sponsors

CCAB Centro Clinico Academico Braga Associacao
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Difference in the total score of the Y-BOCS scale between baseline (V1; before intervention with the investigational drug) and week 16 (V9; after intervention with the investigational drug), between the different groups treated with different doses of pramipexole.

Secondary

MeasureTime frame
Number of adverse events observed (nonserious, serious not related to the investigational medicinal product, and serious related to the investigational medicinal product) from day 2 (V1; after the first dose of the investigational medicinal product) to the week 24 (V11; end of study) in the different pramipexole treatment groups.

Countries

Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026