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To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner 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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| 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) | Mean change from baseline (Day 1) to endpoint in the YMRS total score 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. Total score range is 0 to 60, and the higher value represents worsen. | Day 1 and Day 168 or time of discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania) | Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania) The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill) | Day 1 and Daty 168 or time of discontinuation |
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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
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 |
|---|---|---|---|---|---|---|
| Chugoku Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Hokuriku Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Shikoku Region | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets). |
| 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 |
| |||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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) | Mean change from baseline (Day 1) to endpoint in the YMRS total score 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. Total score range is 0 to 60, and the higher value represents worsen. | Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects) | Posted | Mean | Standard Deviation | scores on a scale | Day 1 and Day 168 or time of discontinuation |
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| Secondary | Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania) | Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania) The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill) | Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects) | Posted | Mean | Standard Deviation | scores on a scale | Day 1 and Daty 168 or time of discontinuation |
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24 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 | Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets). | 4 | 41 | 35 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA(12.1) | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Bipolar I Disorder | Psychiatric disorders | MedDRA(12.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 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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| Diarrhoea | Gastrointestinal disorders | MedDRA(12.1) | Non-systematic Assessment |
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| Constipation | 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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| Nasopharyngitis | Infections and infestations | 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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| Weight Increased | Investigations | MedDRA(12.1) | Non-systematic Assessment |
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| Blood Prolactin Decreased | Investigations | 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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| Akathisia | 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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| Tremor | 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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| Headache | 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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| Blister | Skin and subcutaneous tissue 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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| >=65 years |
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