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Trial record 4 of 6 for:    Manic Episodes paliperidone

A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00309699
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Mood Disorders Drug: Placebo Drug: Quetiapine Drug: Paliperidone ER Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 493 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes in Bipolar Disorder
Study Start Date : April 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Placebo Comparator: 003
Placebo Daily for 3 weeks
Drug: Placebo
Daily for 3 weeks

Active Comparator: 002
Quetiapine 400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks
Drug: Quetiapine
400 to 800 mg daily, initially titrated and flexibly dosed, for 12 weeks

Experimental: 001
Paliperidone ER 3 to 12 mg daily, flexibly dosed, for 12 weeks
Drug: Paliperidone ER
3 to 12 mg daily, flexibly dosed, for 12 weeks




Primary Outcome Measures :
  1. The primary effectiveness outcome is the change in the total YMRS score from baseline to the last assessment during the acute treatment phase. [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. The secondary effectiveness outcomes are the change in GAF from baseline to endpoint or the last assessment during the acute treatment phase and the change in total YMRS score from baseline to endpoint or the last assessment during the maintenance phase. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 YMRS at screening and at baseline
  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309699


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Locations
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United States, California
Cerritos, California, United States
Garden Grove, California, United States
Oceanside, California, United States
San Diego, California, United States
United States, Florida
Bradenton, Florida, United States
Fort Lauderdale, Florida, United States
Kissimmee, Florida, United States
Maitland, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Prairie Village, Kansas, United States
United States, Louisiana
Lake Charles, Louisiana, United States
Shreveport, Louisiana, United States
United States, Mississippi
Flowood, Mississippi, United States
United States, New Jersey
Clementon, New Jersey, United States
United States, Oklahoma
Moore, Oklahoma, United States
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Greece
Athens, Greece
Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Lithuania
Alytus, Lithuania
Vilnius, Lithuania
Russian Federation
Kazan, Russian Federation
Lipetsk, Russian Federation
Moscow Region, Russian Federation
Moscow Russia, Russian Federation
Nizny Novgorod, Russian Federation
Saratov N/A, Russian Federation
St-Petersburg Na, Russian Federation
Taiwan
Changhua, Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Taipei, Taiwan
Turkey
Ankara, Turkey
Diyarbakir, Turkey
Istanbul, Turkey
Ukraine
Donetsk, Ukraine
Glevakha, Ukraine
Kharkov, Ukraine
Kiev, Ukraine
Odessa, Ukraine
Simferopol, Ukraine
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00309699     History of Changes
Other Study ID Numbers: CR010858
R076477BIM3002
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
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Paliperidone Palmitate
Disease
Bipolar Disorder
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents