Trial intelligence / Profile preview

Pramipexole Augmentation of Quetiapine XR in Bipolar Depression

NCT00893841Phase 2

Key facts

Status: Completed
Start: Feb 2009
Primary completion: Jan 2013
Countries: 2
Sponsor: McIntosh & Kjernisted Clinical Research
Modality: Small Molecules

Drugs: pramipexole
Conditions: bipolar disorder (BD)

Overview

Phase 2, randomised, double-blind trial of pramipexole in bipolar disorder (BD) (3 arms), sponsored by McIntosh & Kjernisted Clinical Research. Primary endpoint: Montgomery-Asberg Depression Rating Scale at 16 weeks. Started Feb 2009; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Placebo Comparator
Quetiapine XR 300mg + Placebo
Experimental Low Dose
Quetiapine XR 300mg + Pramipexole 0.25mg
Experimental High Dose
Quetiapine XR 300mg + Pramipexole 0.50mg

Who it enrols

Adult patients aged 18-65 with bipolar depression, excluding those with other primary psychotic disorders, substance dependence, or unstable medical conditions.

Endpoints

Primary

Montgomery-Asberg Depression Rating Scale16 weeks

Secondary

Montgomery-Asberg Depression Rating Scale Change8 weeks
Proportion of subjects achieving remission16 weeks
Proportion of subjects achieving response16 weeks
Hamilton Depression Rating Scale Change16 weeks
Proportion of subjects achieving remission (HAM-D)16 weeks
Proportion of subjects achieving response (HAM-D)16 weeks
Vancouver Semi-Structured Interview for Depression Change16 weeks
Withdrawal due to inadequate control16 weeks

Beyond the preview

Go deeper on NCT00893841.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00893841.