Clinical trial NCT00132678: A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Mood episodes
Bipolar 1 disorder
Intramuscular Injectable
risperidone
safety and efficacy
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants Who Had a Mood Relapse.
timeFrame: 24 months
Secondary outcomes:
measure: Change in Young Mania Rating Scale (YMRS) Scores.
timeFrame: Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV
measure: Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: La Mesa
country: United States
state: California
city: National City
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Lake Charles
country: United States
state: Louisiana
city: Towson
country: United States
state: Maryland
city: Clementon
country: United States
state: New Jersey
city: Lyndhurst
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Desoto
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Neunkirchen
country: Austria
city: Bangalore
country: India
city: Hyderabad
country: India
city: Manipal
country: India
city: Johor Bahru
country: Malaysia
city: Kota Bharu
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Choroszcz N/A
country: Poland
city: Gdansk
country: Poland
city: Swiecie Poland
country: Poland
city: Tuszyn N/A
country: Poland
city: Lipetsk
country: Russian Federation
city: Moscow N/A
country: Russian Federation
city: Moscow Region
country: Russian Federation
city: Moscow Russia
country: Russian Federation
city: Nizny Novgorod
country: Russian Federation
city: Samara N/A
country: Russian Federation
city: Saratov N/A
country: Russian Federation
city: St Petersburg N/A
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: St-Petresburg
country: Russian Federation
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Dnepropetrovsk
country: Ukraine
city: Glevakha
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Lvov
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol
country: Ukraine
city: Vinnitsa
country: Ukraine
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.