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A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release Paliperidone in Subjects With Bipolar I Disorder
This study has been completed.
First Received: March 3, 2006   Last Updated: June 16, 2008   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00299715
  Purpose

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.


Condition Intervention Phase
Mood Disorders
Bipolar Disorder
Drug: Paliperidone extended-release
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response, Multicenter Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release Paliperidone in the Treatment of Subjects With 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 the total Young Mania Rating Scale score from baseline to the last assessment during the 3 week double-blind treatment phase.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 464
Study Start Date: January 2006
Study Completion Date: June 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299715

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR010834
Study First Received: March 3, 2006
Last Updated: June 16, 2008
ClinicalTrials.gov Identifier: NCT00299715     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
mania
manic-depressive
mixed-state
paliperidone
bipolar disorder
paliperidone ER.
manic disorder
Affective psychosis
manic state
psychosis

Additional relevant MeSH terms:
Disease
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
9-hydroxy-risperidone
Antipsychotic Agents
Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009