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To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") in a double-blind manner to those patients who complete Study 003 and demonstrate drug efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | oral, 24mg(4 tablets)/day |
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| Measure | Description | Time Frame |
|---|---|---|
| Young Mania Rating Scale (YMRS) | Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group. YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). | Baseline (Day 1 of preceding study) , Day 154 or at discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania) | Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group. CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components-mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill). |
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Inclusion Criteria:
Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
Subjects have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
Subjects who were enrolled in and have completed Study 003 and who meet the following criteria for demonstration of drug efficacy
Subjects demonstrating drug efficacy:
Exclusion Criteria:
Subjects presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
Subjects who represent a significant risk of committing suicide
Subjects known to have a complication of allergy to aripiprazole or other quinolinone-skeleton compounds
Subjects with a complication of neuroleptic malignant syndrome
Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
Subjects with a complication of paralytic ileus
Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy
Subjects with a complication of diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | Department of Clinical Research and Development, Division of New Product Evaluation and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | China | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Patients who had completed the preceding study and demonstrated drug efficacy were the target. Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo | Drug | oral, 0mg(4tablets)/day |
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| Baseline (Day 1 of preceding study), Day 154 or at discontinuation |
| Chubu Region |
| Japan |
| Chugoku Region | Japan |
| Hokkaido Region | Japan |
| Hokuriku Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| Seoul | South Korea |
| Taipei | Taiwan |
Patients who had completed the preceding study and demonstrated drug efficacy were the target.
Subjects were administered placebo once daily for 154 days.
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Population(FAS)：Excluding 3 subject with GCP violation from the randomized subjects.
(Aripiprazole:1, Placebo:2)
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Patients who had completed the preceding study and demonstrated drug efficacy were the target. Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days. |
| BG001 | Placebo | Patients who had completed the preceding study and demonstrated drug efficacy were the target. Subjects were administered placebo once daily for 154 days. |
| 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 |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Young Mania Rating Scale (YMRS) | Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group. YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). | FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 1 of preceding study) , Day 154 or at discontinuation |
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| Secondary | Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania) | Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group. CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components-mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill). | FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis. | Posted | Mean | Standard Deviation | scores on scale | Baseline (Day 1 of preceding study), Day 154 or at discontinuation |
|
22 weeks
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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 | Aripiprazole | Patients who had completed the preceding study and demonstrated drug efficacy were the target. Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days. | 7 | 54 | 46 | 54 | ||
| EG001 | Placebo | Patients who had completed the preceding study and demonstrated drug efficacy were the target. Subjects were administered placebo once daily for 154 days. | 4 | 42 | 26 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA(12.1) | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Stupor | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Bipolar I Disorder | Psychiatric disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Bipolar Disorder | Psychiatric disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Delusion of Grandeur | Psychiatric disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Salivary Hypersecretion | Gastrointestinal disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA(12.1) | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA(12.1) | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA(12.1) | Non-systematic Assessment |
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| Weight Increased | Investigations | MedDRA(12.1) | Non-systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA(12.1) | Non-systematic Assessment |
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| Muscle Rigidity | Musculoskeletal and connective tissue disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Bradykinesia | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| China |
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| Japan |
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| Malaysia |
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| Indonesia |
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| Philippines |
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| Units | Counts |
|---|---|
| Participants |
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