A Study to Evaluate the Effectiveness and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder. - Full Text View

Sponsored by:	Janssen-Cilag G.m.b.H
Information provided by:	Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:	NCT00391222

Purpose

The purpose of the study is to evaluate the efficacy of risperidone long-acting injectable in comparison with placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder. This study tests the safety and effectiveness of a drug called risperidone Long Acting Injectable (LAI). Placebo treatment, and another drug called olanzapine are used to assess the validity of the study design. The purpose of this research study is to see if risperidone LAI can help keep patients who have bipolar disorder from having another mood episode. Risperidone LAI is injected into a muscle.

The risperidone contained in the long acting injection slowly moves out of the spot where the injection was made and is taken up by the blood.

Risperidone LAI has been approved by the FDA in the USA and health authorities in many European and other countries for use in patients with schizophrenia. Risperidone as a tablet has been approved for use in patients with the following conditions: schizophrenia and delaying relapse in schizophrenia and bipolar mania. Outside the United States risperidone has been approved for the treatment of mania in adults, behavioral and psychotic symptoms of dementia (BPSD), and conduct disorder in children and adults.

Condition	Intervention	Phase
Bipolar I Disorder	Drug: Long-acting intramuscular injectable (LAI) risperidone; risperidone depot microspheres	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Placebo and Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Risperidone Long-Acting Injectable (LAI) for the Prevention of Mood Episodes in the Treatment of Subjects With Bipolar I Disorder

Further study details as provided by Janssen-Cilag G.m.b.H:

Primary Outcome Measures:

Time to a recurrence of a mood episode in the double-blind period (Period III) will be the primary outcome. When the criteria for recurrence event in Period III is met, the investigator will classify the type of mood episode (DSM-IV-TR criteria).

Secondary Outcome Measures:

Time to recurrence in Period III of an elevated-mood episode, time to recurrence in Period III of a depressive episode and time to early discontinuation from study medication for any reason.

Estimated Enrollment:	860
Study Start Date:	September 2006

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:

Diagnosis of bipolar I disorder as defined by DSM-IV-TR criteria. All diagnoses will be confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.). Patients who present with additional signs or symptoms compatible with Axis I diagnoses of social anxiety disorder or generalized anxiety disorder are acceptable. All other comorbid or active Axis I diagnoses are excluded. Personality disorders as defined by DSM IV TR criteria are acceptable, with the exception of antisocial and borderline personality disorders
Must be currently experiencing a manic or mixed episode (acute
YMRS >20 and CGI-S =>4 [moderate]) or must be between mood episodes (non-acute
YMRS <12 and CGI-S=<3 [mild])
Must have had at least 2 bipolar mood (manic, mixed manic, or depressed) episodes, exclusive of the current episode (if applicable), during the last year. For non-acute subjects (YMRS <12 and CGI-S=<3 [mild]), one manic episode must have occurred within 4 months of enrollment
Patients who are non-acute (YMRS <12 and CGI-S =<3 [mild]) and are currently receiving an antipsychotic other than risperidone or a mood stabilizer must have received this other medication at the same dosage for a minimum of 4 weeks and must be either experiencing problems of safety or tolerability with the antipsychotic or mood stabilizer or request a change of medication

Exclusion Criteria:

No history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening
No history of ADHD, anxiety disorder, or panic disorder as the primary diagnosis
Not meeting DSM-IV-TR criteria for a hypomanic or depressive episode
Not meeting DSM-IV-TR criteria for any comorbid or active Axis I disorder other than those specifically allowed in the Inclusion Criteria
Not meeting DSM-IV-TR criteria for antisocial or borderline personality disorder
Not having a chronic or serious general medical illness, including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic (including seizure disorder), or hematologic disease as determined by the clinical judgment of the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391222

Sponsors and Collaborators

Janssen-Cilag G.m.b.H

Investigators

Study Director:

Janssen-Cilag G.m.b.H. Clinical Trial

Janssen-Cilag G.m.b.H

More Information

No publications provided

Study ID Numbers:	CR012145
Study First Received:	October 20, 2006
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00391222 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Janssen-Cilag G.m.b.H:

long acting injectable
prevention of mood episodes
Intramuscular injection
Bipolar I Disorder
risperidone

Study placed in the following topic categories:

Neurotransmitter Agents
Dopamine
Tranquilizing Agents
Psychotropic Drugs
Risperidone

Central Nervous System Depressants
Dopamine Agents
Antipsychotic Agents
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009