# A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.

> **NCT00250367** · PHASE3 · COMPLETED · sponsor: **Janssen Pharmaceutica N.V., Belgium** · enrollment: 151 (actual)

## Conditions studied

- Bipolar Disorder
- Manic Disorder

## Interventions

- **DRUG:** risperidone

## Key facts

- **NCT ID:** NCT00250367
- **Lead sponsor:** Janssen Pharmaceutica N.V., Belgium
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 1997-10
- **Primary completion:** —
- **Final completion:** 1999-11
- **Target enrollment:** 151 (ACTUAL)
- **Last updated:** 2010-11-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00250367

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00250367, "A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT00250367. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*