A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-release Paliperidone in Subjects With Bipolar I Disorder

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Paliperidone Palmitate

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 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

• in the opinion of the study doctor, is at significant risk for suicidal or violent behavior during the course of the study

• known or suspected history of substance dependence (excluding nicotine and caffeine) within the previous 3 months

• serious or unstable, medical illness (e.g., cardiovascular disease, neurologic, hematologic, renal, immunologic, metabolic, or other systemic illness), or has a history of uncontrolled or insulin-dependent diabetes mellitus

• history of severe, pre-existing gastrointestinal narrowing or inability to swallow study drug with the aid of water

• results at screening or baseline for liver function tests greater than twice the upper limit of the central laboratory reference range

• has active hypo- or hyperthyroidism unless stabilized on appropriate medication for at least 3 months before the screening phase

• history of neuroleptic malignant syndrome

• has a moderate-to-severe degree of tardive dyskinesia at screening

• known or suspected history of hypersensitivity or intolerance to paliperidone or risperidone or suspected history of life-threatening drug allergy or hypersensitivity to any drug

• 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

• use of clozapine, aripiprazole, or fluoxetine within 1 month before the screening phase

• has received antidepressant therapy, other than fluozetine, within 7 days before the first dose of study drug

• use of antiparkinsonian drugs or beta-blockers (for any indication other than hypertension) within 3 days before the first dose of study drug

• have 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

• alcohol intoxication within 3 days before the first dose of study drug

• has had an injection of RISPERDAL CONSTA within 5 weeks before the screening phase, or has received another depot antipsychotic within 1 treatment cycle before the screening phase

• electroconvulsive therapy within 6 months before the first dose of study drug

• women who are pregnant or nursing

• has an anticipated life expectancy of 6 months or less.