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| ID | Type | Description | Link |
|---|---|---|---|
| RISBIM3003 |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks |
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| 002 | Placebo Comparator | Placebo Matching placebo intramuscular (IM) injection every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperdal Consta | Drug | 12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Young Mania Rating Scale (YMRS) Scores. | Measure of mania; score range 0 to 60 (lower score = less severity) | Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV |
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20227682 | Derived | 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. |
| Label | URL |
|---|---|
| A study of the efficacy and safety of injectable risperidone in the prevention of bipolar mood episodes | View source |
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Subjects with an acute episode or who were stable on another antipsychotic entered Period II; Period II responders entered Period III. Subjects stable on RIS at screening entered Period III directly. Subjects who maintained response and had a stable dose of RIS LAI for the last 8 weeks of Period III were randomized to RIS LAI or placebo(Period IV).
A total of 559 (440 + 119) subjects received at least one dose of study drug. A total of 440 subjects (acute episode or stable on other antipsychotic) entered period II, 382 subjects completed and entered period III. An additional 119 subjects (stable on risperidone) entered period III directly. Overall 501 (382 + 119) subjects entered period III.
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| ID | Title | Description |
|---|---|---|
| FG000 | RISPERDAL CONSTA | risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks |
| FG001 | Placebo | intramuscular (IM) injection every 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period II (Open-Label Oral Risperidone) |
|
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| Placebo |
| Drug |
Matching placebo intramuscular (IM) injection every 2 weeks |
|
Measure of depression; score range 0 to 60 (lower score = less severity) |
| Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV |
| La Mesa |
| California |
| United States |
| National City | California | United States |
| Washington D.C. | District of Columbia | United States |
| Bradenton | Florida | United States |
| Hialeah | Florida | United States |
| Lake Charles | Louisiana | United States |
| Towson | Maryland | United States |
| Clementon | New Jersey | United States |
| Lyndhurst | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| DeSoto | Texas | United States |
| Richmond | Virginia | United States |
| Neunkirchen | Austria |
| Bangalore | India |
| Hyderabad | India |
| Manipal | India |
| Johor Bahru | Malaysia |
| Kota Bharu | Malaysia |
| Kuala Lumpur | Malaysia |
| Choroszcz | Poland |
| Gdansk | Poland |
| Swiecie Poland | Poland |
| Tuszyn | Poland |
| Lipetsk | Russia |
| Moscow | Russia |
| Moscow Region | Russia |
| Moscow Russia | Russia |
| Nizny Novgorod | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Saratov | Russia |
| St-Petresburg | Russia |
| Bratislava | Slovakia |
| Košice | Slovakia |
| Rimavská Sobota | Slovakia |
| Barcelona | Spain |
| Madrid | Spain |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| Dnipro | Ukraine |
| Hlevakha | Ukraine |
| Kharkiv | Ukraine |
| Kiev | Ukraine |
| Lviv | Ukraine |
| Odesa | Ukraine |
| Simferopol | Ukraine |
| Vinnitsa | Ukraine |
| FG002 | Open-Label Oral Risperidone | (flexible dosage) 1 to 6 mg/day for the first 3 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| Period III (Open-Label Stabilization) |
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| Period IV (Double-Blind Treatment) |
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| ID | Title | Description |
|---|---|---|
| BG000 | RISPERDAL CONSTA | risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks |
| BG001 | Placebo | IM injection every 2 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Intention to treat. 28 subjects from a Good Clinical Practice noncompliant site and 1 site with alleged research misconduct were excluded from efficacy analyses. The median (interquartile range) for time to relapse (d): Risperdal Consta: NA (173, NA) & Placebo: 219 (82, NA) [NA = not available; Risperdal Consta relapse percent < 50% & Placebo <75%] | Posted | Number | Participants | 24 months |
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| Secondary | Change in Young Mania Rating Scale (YMRS) Scores. | Measure of mania; score range 0 to 60 (lower score = less severity) | Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient's last nonmissing, postbaseline value in Period IV (last observation carried forward technique) | Posted | Mean | Standard Deviation | units on a scale | Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV |
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| Secondary | Change in Montgomery-Åsberg Depression Rating Scale (MADRS) | Measure of depression; score range 0 to 60 (lower score = less severity) | Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient's last nonmissing, postbaseline value in Period IV (last observation carried forward technique) | Posted | Mean | Standard Deviation | units on a scale | Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RISPERDAL CONSTA | Double-blind Period IV. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks. | 13 | 154 | 28 | 154 | ||
| EG001 | Placebo | Double-blind Period IV. Intramuscular (IM) injection every 2 weeks | 25 | 149 | 24 | 149 | ||
| EG002 | Open-Label Oral Risperidone | Open-label Period II. Flexible dosage. 1 to 6 mg/day for the first 3 weeks | 8 | 440 | 81 | 440 | ||
| EG003 | Open Label RISPERDAL CONSTA | Open-label Period III. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks. | 38 | 501 | 155 | 501 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Drug dependence | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Mental disorder | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
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| Hepatic rupture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
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| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
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| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
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| Accidental death | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Sommolence | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment | Number affected in Open-Label RISPERDAL CONSTA does not include the event of insomnia in the Serious Adverse Event table. |
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| Anxiety | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment | Number affected in Open-Label RISPERDAL CONSTA does not include the event of anxiety in the Serious Adverse Event table. |
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| Agitation | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Johnson & Johnson Pharmaceutical Research and Development | 609 730-4576 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Non responder |
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| Ineligible to continue trial |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Subject non-compliant |
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| Physician Decision |
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| Pregnancy |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Physician Decision |
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| Subject Non-compliant |
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| Pregnancy |
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| Male |
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