Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Affective Psychosis, Bipolar
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
Several treatments are available for the treatment of acute manic and mixed episodes associated with bipolar disorder. Some of these treatments, including lithium, divalproex sodium, and carbamazepine...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00309686
Start Date
April 1 2006
End Date
August 1 2007
Last Update
May 18 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.