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The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | oral, 24mg/day |
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| Measure | Description | Time Frame |
|---|---|---|
| Young Mania Rating Scale (YMRS) | Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA). 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) elevated 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). | Day1, Day21 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania) | 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). Using LOCF datasets, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA. |
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Inclusion Criteria:
Exclusion Criteria:
Patients presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
Patients experiencing their first manic or mixed episode
Patients whose current manic episode has lasted for more than 4 weeks
Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders, but including abuse of benzodiazepines)
Patients who have received ECT treatment within 8 weeks prior to informed consent
Patients who are expected to require administration of ultrashort-acting or short-acting benzodiazepine receptor agonist hypnotics and antianxiety drugs (See (1) of 4.2.2) at doses exceeding the equivalent of 15 mg/day of diazepam (Only for those patients using such drugs)
Patients at significant risk of developing a severe adverse event. Patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the trial, or who have a history of such a condition.
Patients who have received any of the following treatments during the screening period:
For patients who take lithium, valproate, or carbamazepine within 3 days prior to commencement of investigational product administration, those patients with serum concentrations of lithium greater than 0.6 mmol/L, serum concentrations of valproate greater than 50 µg/mL, or serum concentrations of carbamazepine greater than 4 µg/mL
Patients judged to have a diabetic blood glucose level (judgment based on use of a self-monitoring blood glucose meter permissible), or patients whose HbA1c is 6.5% or higher
Patients with a history or 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 | Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo |
| Drug |
oral, 0mg(4tablets)/day |
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| Day1, Day21 |
| 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 |
Subjects were administered placebo once daily for 21 days.
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| NOT COMPLETED |
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Full Analysis Population(FAS)：
Excluding the following subjects from the randomized subjects:
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day. |
| BG001 | Placebo | Subjects were administered placebo once daily for 21 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, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA). 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) elevated 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). | Full analysis set (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 | Least Squares Mean | Standard Error | scores on a scale | Day1, Day21 |
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| Secondary | Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania) | 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). Using LOCF datasets, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA. | 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 | Least Squares Mean | Standard Error | scores on a scale | Day1, Day21 |
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21 weeks
1 subject in the placebo group took the study medication (aripiprazole) before proper randomization and was later assigned to the placebo group by IVRS. It was decided to include this subject in the aripiprazole group for safety analysis. However, she was included in the placebo group for the FAS.
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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 | Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day. | 5 | 123 | 69 | 123 | ||
| EG001 | Placebo | Subjects were administered placebo once daily for 21 days. | 9 | 125 | 45 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | 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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| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA(12.1) | Non-systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue 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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| 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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| Drug Erption | Skin and subcutaneous tissue 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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| Nausea | 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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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA(12.1) | Non-systematic Assessment |
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| Akathisia | 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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| Tremor | 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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| 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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| Indonesia |
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| Malaysia |
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| Philippines |
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