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

NCT00299715 | Completed Phase 3

• 1 other identifier: CR010834
• Study Type: interventional
• Target: 473
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bipolar Disorder; Mood Disorders

Keywords

Affective psychosis; mixed-state; bipolar disorder; manic disorder; manic-depressive; psychosis; mania; manic state; paliperidone; paliperidone ER.

Outcome Measures

Primary Outcomes (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.

Secondary Outcomes (1)

• The secondary effectiveness outcome is the change in Global Assessment of Functional Scale from baseline to endpoint or the last assessment during the double-blind treatment phase.

Interventions

Paliperidone extended-release DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Berwaerts J, Xu H, Nuamah I, Lim P, Hough D. Evaluation of the efficacy and safety of paliperidone extended-release in the treatment of acute mania: a randomized, double-blind, dose-response study. J Affect Disord. 2012 Jan;136(1-2):e51-e60. doi: 10.1016/j.jad.2010.06.030. Epub 2010 Jul 10.

  PMID: 20624657 DERIVED

Related Links

• A study to evaluate the efficacy and safety of three fixed doses of extended-release paliperidone in subjects with Bipolar I disorder.

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders; Affective Disorders, Psychotic; Psychotic Disorders; Mania

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2006
• First Posted: March 7, 2006
• Study Start: February 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: June 9, 2011

Record last verified: 2011-06