# A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder

> **NCT00309686** · PHASE3 · COMPLETED · sponsor: **Johnson & Johnson Pharmaceutical Research & Development, L.L.C.** · enrollment: 300 (actual)

## Conditions studied

- Affective Psychosis, Bipolar
- Bipolar Disorder
- Mania

## Interventions

- **DRUG:** Paliperidone ER

## Key facts

- **NCT ID:** NCT00309686
- **Lead sponsor:** Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-04
- **Primary completion:** —
- **Final completion:** 2007-08
- **Target enrollment:** 300 (ACTUAL)
- **Last updated:** 2011-05-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00309686

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00309686, "A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT00309686. Licensed CC0.

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