A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder

NCT00391222 | Completed Phase 3 Results

• 1 other identifier: CR012145
• Study Type: interventional
• Target: 585
• Locations: 15 countries
• Sites: 63

Brief Summary

The purpose of this randomized, double blind, double dummy, multicenter study was to evaluate the efficacy of risperidone long-acting injectable (LAI) monotherapy in comparison with placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder. Oral olanzapine was used to assess the validity of the study design. The primary objective of this study is to evaluate the efficacy of risperidone LAI versus placebo in the prevention of a mood episode (recurrence event) in patients with bipolar I disorder after a 12-week (3 month) stabilization period on risperidone LAI, as measured by the time to recurrence of any mood episode. Risperidone LAI has been approved by the FDA in the USA for the treatment of patients with schizophrenia and for the prevention of mood recurrences in bipolar I disorder, as monotherapy or add-on treatment. It is approved at EMEA and other European and non-European health authorities for the treatment of patients with schizophrenia, too.

Conditions

Bipolar Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo)

  Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) \>12 or Montgomery-Åsberg Depression Rating Scale (MADRS) \>12 combined with Clinical Global Impression - Severity (CGI-S) \>=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.

  Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Secondary Outcomes (6)

• Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode

  Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

• Time to Recurrence of a Depressive Episode

  Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

• Time to Early Study Discontinuation for Any Reason

  Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

• Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS)

  Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

• Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS)

  Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Study Arms (3)

001

EXPERIMENTAL

Risperidone Long Acting Injectable (LAI) Intramuscular injections of risperidone LAI (25 37.5 or 50 mg) every 2 weeks and oral placebo daily

Drug: Risperidone Long Acting Injectable (LAI)

002

PLACEBO COMPARATOR

Placebo Intramuscular injections of placebo every 2 weeks and oral placebo daily

Drug: Placebo

003

ACTIVE COMPARATOR

Olanzapine Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily

Drug: Olanzapine

Interventions

Olanzapine DRUG

Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily

003

Placebo DRUG

Intramuscular injections of placebo every 2 weeks and oral placebo daily

002

Risperidone Long Acting Injectable (LAI) DRUG

Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily

001

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (63)

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Baoding, China

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Beijing, China

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Guangzhou, China

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Nanjing, China

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Shanghai, China

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Suozhou, China

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Wuhan, China

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Barranquilla Atlantico, Colombia

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Bello Antioquia, Colombia

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Bogotá, Colombia

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Bogotá S/N, Colombia

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Medellin Antioquia, Colombia

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Pereira Risaralda, Colombia

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Freiburg im Breisgau, Germany

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Hildesheim, Germany

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Oranienburg, Germany

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Athens, Greece

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Ahmedabad, India

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Bangalore, India

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Chennai, India

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Hyderabad, India

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Ludhiana, India

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Mangalore, India

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Mumbai, India

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New Delhi, India

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Pune, India

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Varanasi, India

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Jakarta, Indonesia

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Amman, Jordan

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Beirut, Lebanon

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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Mexico City, Mexico

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Mérida, Mexico

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Monterrey, Mexico

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Puebla City, Mexico

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Tabasco, Mexico

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Tampico, Mexico

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Zapopan, Mexico

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Lima, Peru

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Lima Lima, Peru

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Iloilo City, Philippines

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Mandaluyong, Philippines

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Mandaue City, Philippines

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Arkhangelsky District, Russia

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Chelyabinsk, Russia

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Izhevsk, Russia

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Kazan’, Russia

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Moscow, Russia

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Moscow Region, Russia

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Nizny Novgorod, Russia

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Orenburg, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Stavropol Na, Russia

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Tomsk Na, Russia

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Voronezh, Russia

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Bloemfontein, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Pretoria, South Africa

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Tainan, Taiwan

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Taipei, Taiwan

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Related Links

• A randomized, double-blind, placebo and active-controlled, parallel-group study to evaluate the efficacy and safety of risperidone long-acting injectable for the prevention of mood episodes in the treatment of subjects with bipolar I disorder

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: EMEA Medical Affairs Director
• Organization: Janssen Cilag Spain

+34 91 7228043

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 23, 2006
• Study Start: November 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 9, 2014
• Results First Posted: November 1, 2010

Record last verified: 2014-04

Locations

RU (13); JO (1); ME (7); CN (7); PH (3); ZA (4); PE (2); CO (6); TW (2); GR (1); ID (1); DE (3); IN (10); MY (2); LE (1)