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Bipolar DisorderPhase 3NCT00132678

A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes

A Phase 3 study testing Risperdal Consta in people with Bipolar Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 51 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder
What is being tested?
Risperdal Consta
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
559 participants
Where
51 sitesin 10 countries
Study dates
Feb 2005to Dec 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable
  • Two or more bipolar mood episodes in the last 2 years excluding current episode
  • Negative pregnancy test

Who cannot join

  • History of > than 4 mood episodes a year during the last two years
  • patients experiencing a depressive episode
  • History of antisocial or borderline personality illness
  • Has unstable or serious general medical illness
  • Has received medications disallowed by study criteria.

Trial locations and contacts

51 sites in 10 countries.

51 sites in 10 countries

United States14 sites

  • Study site

    Bradenton, Florida

  • Study site

    Clementon, New Jersey

  • Study site

    DeSoto, Texas

  • Study site

    Hialeah, Florida

  • Study site

    La Mesa, California

  • Study site

    Lake Charles, Louisiana

  • Study site

    Little Rock, Arkansas

  • Study site

    Lyndhurst, Ohio

  • Study site

    National City, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Richmond, Virginia

  • Study site

    Towson, Maryland

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Russia9 sites

  • Study site

    Lipetsk

  • Study site

    Moscow

  • Study site

    Moscow Region

  • Study site

    Moscow Russia

  • Study site

    Nizny Novgorod

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Saratov

  • Study site

    St-Petresburg

Other trials in Russia

Ukraine8 sites

  • Study site

    Dnipro

  • Study site

    Hlevakha

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Simferopol

  • Study site

    Vinnitsa

Other trials in Ukraine

Poland4 sites

  • Study site

    Choroszcz

  • Study site

    Gdansk

  • Study site

    Swiecie Poland

  • Study site

    Tuszyn

Other trials in Poland

Taiwan4 sites

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

India3 sites

  • Study site

    Bangalore

  • Study site

    Hyderabad

  • Study site

    Manipal

Other trials in India

Malaysia3 sites

  • Study site

    Johor Bahru

  • Study site

    Kota Bharu

  • Study site

    Kuala Lumpur

Other trials in Malaysia

Slovakia3 sites

  • Study site

    Bratislava

  • Study site

    Košice

  • Study site

    Rimavská Sobota

Other trials in Slovakia

Spain2 sites

  • Study site

    Barcelona

  • Study site

    Madrid

Other trials in Spain

Austria1 site

  • Study site

    Neunkirchen

Other trials in Austria

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Explore the Efficacy and Safety of Risperidone Long-acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar 1 Disorder, With Open-label Extension

The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.

Read the detailed description

RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement, by reducing patient non-compliance, in the long-term treatment of bipolar I disorder. This is a randomized (patients are assigned different treatments based on chance), double-blind, (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) placebo-controlled study to explore the safety and effectiveness of RISPERDAL CONSTA in the prevention of mood episodes in patients with bipolar 1 disorder. This study includes 5 periods: a screening period lasting up to 1 week; an open-label RISPERDAL (oral risperidone) treatment period lasting 3 weeks; an open-label RISPERDAL CONSTA stabilization period lasting 26 weeks; a double-blind period lasting up to 24 months; and an open-label extension with RISPERDAL CONSTA lasting 8 weeks. Efficacy will be assessed using the Young Mania Rating Scale (YMRS), Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions - Severity (CGI-S) scale, Medical Outcomes Study Short Form 36 (SF-36), and the Personal and Social Performance (PSP) scale. Safety will be evaluated throughout the study and includes assessment of adverse events, clinical laboratory tests (including hematology, serum chemistry, blood glucose/lipid profile, prolactin, and urinalysis); electrocardiograms (ECGs), vital signs (pulse and blood pressure), physical examination, body mass index (BMI), and the Extrapyramidal Symptom Rating Scale (ESRS). Oral risperidone (flexible dosage) 1 to 6 mg/day for the first 3 weeks. Risperidone LAI i.m. injections (12.5mg, 25 mg, 37.5 mg, or 50 mg) given every 2 weeks for up to approximately 2.6 years (only 6 months for patients receiving placebo during DB-period)

Being tested
Risperdal Consta, Placebo
Keywords
Mood episodes, Bipolar 1 disorder, Intramuscular Injectable, risperidone, safety and efficacy
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risperdal ConstaDrug

    12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks

  • PlaceboDrug

    Matching placebo intramuscular (IM) injection every 2 weeks

Study groups in NCT00132678
Study groupRoleWhat they receive
001ExperimentalRisperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks
Receives: Drug: Risperdal Consta
002Placebo comparatorPlacebo Matching placebo intramuscular (IM) injection every 2 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Had a Mood Relapse.

    Mood Relapse was defined as:

    The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score >12 or a CGI-S score >4; or a dose increase, or supplementation with oral risperidone or another antipsychotic or mood stabilizer, was needed in the opinion of the investigator.

    Measured: 24 months

Secondary outcomes (2)

  1. Change in Young Mania Rating Scale (YMRS) Scores.

    Measure of mania; score range 0 to 60 (lower score = less severity)

    Measured: Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV

  2. Change in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Measure of depression; score range 0 to 60 (lower score = less severity)

    Measured: Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionOct 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00132678
Sponsor's protocol ID
CR002278
Other IDs
RISBIM3003
Status last verified
Jul 2013
First submitted
30 Jun 2005
Last updated
29 Jul 2013
Data monitoring committee
No

Publications

  • Quiroz JA, Yatham LN, Palumbo JM, Karcher K, Kushner S, Kusumakar V. Risperidone long-acting injectable monotherapy in the maintenance treatment of bipolar I disorder. Biol Psychiatry. 2010 Jul 15;68(2):156-62. doi: 10.1016/j.biopsych.2010.01.015. Epub 2010 Mar 15.

    PubMed 20227682

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risperdal Consta in people with Bipolar Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 51 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Russia, Ukraine, Poland, Taiwan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Had a Mood Relapse. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00132678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.

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