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
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00309686
First received: March 31, 2006
Last updated: May 17, 2011
Last verified: March 2010
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Purpose
The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are experiencing a manic or mixed episode while they are taking lithium or valproate. This study will also evaluate the effect of paliperidone ER compared with placebo on overall functioning, on how quickly a response is seen, on improvement in severity of illness, on health-related functional status, on depressive symptoms, and on psychotic symptoms. The relationship between blood levels and the effectiveness and safety of paliperidone ER will be evaluated, including the effect of food relative to time of taking the drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Affective Psychosis, Bipolar Bipolar Disorder Mania |
Drug: Paliperidone ER |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic and Mixed Episodes Associated With Bipolar I Disorder |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- The primary effectiveness outcome is the change in total YMRS score from baseline (first dose) to the last assessment in the 6-week double-blind treatment phase.
Secondary Outcome Measures:
- The secondary effectiveness outcome is the change in GAF score from baseline (first dose) to the last assessment in the 6-week double-blind treatment phase.
| Enrollment: | 300 |
| Study Start Date: | April 2006 |
| Study Completion Date: | August 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meets Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features)
- History of at least 1 previously documented manic or mixed episode requiring medical treatment within the past 3 years
- Must have been taking lithium or valproate as part of treatment for Bipolar I Disorder for at least 2 weeks before screening, with drug levels at screening within therapeutic range
- Total YMRS score of at least 20 at screening and at baseline (Day 1)
- Women must be postmenopausal for at least 2 years or agree to practice an effective method of birth control throughout the study.
Exclusion Criteria:
- Meets DSM-IV criteria for rapid cycling and schizoaffective disorder
- In the opinion of the study doctor, is at significant risk for suicidal or violent behavior during the course of the study
- Has used cocaine, phencyclidine, amphetamine, methylphenidate, pemoline, an opioid (excluding codeine), hallucinogen, or any other drug that may be associated with manic symptoms as evidenced by a positive urine drug screen
- Has received benzodiazepines at doses equal to 4 mg/day of lorazepam or higher for a period of 3 months or longer immediately before the screening phase.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309686
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Additional Information:
No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00309686 History of Changes |
| Other Study ID Numbers: | CR010855 |
| Study First Received: | March 31, 2006 |
| Last Updated: | May 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Affective psychosis bipolar disorder manic disorder manic-depressive psychosis mania |
manic state paliperidone paliperidone ER adjunctive therapy |
Additional relevant MeSH terms:
|
Affective Disorders, Psychotic Bipolar Disorder Mental Disorders Psychotic Disorders Mood Disorders Schizophrenia and Disorders with Psychotic Features 9-hydroxy-risperidone Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013