A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-release Paliperidone… (NCT00299715) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-release Paliperidone in Subjects With Bipolar I Disorder
473 participantsStarted 2006-02
Plain-language summary
The purpose of this study is to evaluate the effectiveness and safety of 3 different doses of paliperidone extended release (ER) compared to placebo in patients diagnosed with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone extended release on global functioning, and the relationship between blood levels and the effectiveness and safety of paliperidone.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 3 years before the screening phase
* total score of at least 20 on the Young Mania Rating Scale at screening and at baseline visit
* if taking mood stabilizers, antipsychotics, or antimanic drugs, must have discontinued that medication at least 3 days before baseline
* women must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization)
* able and willing to comply with self-administration of medication, or have consistent help or support available.
Exclusion Criteria:
* Meets Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition criteria for any type of episode associated with Bipolar disorder other than Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features)
* meets DSM-IV criteria for rapid cycling and schizoaffective disorder
* known or suspected borderline or antisocial personality disorder
* …
What they're measuring
1
The primary effectiveness outcome is the change in the total Young Mania Rating Scale score from baseline to the last assessment during the 3 week double-blind treatment phase.
Trial details
NCT IDNCT00299715
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.