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Supply Omega-3 Fatty Acids expired and supplier no longer made same composition.
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This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as follows:
Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of children and adolescents with BPD
Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active omega-3 treatment
Initial clinical evidence suggests that the omega-3 fatty acids EPA (eicosapentaenoic acid) and/or DHA (docosahexaenoic acid) may play a therapeutic role in the management of mood disorders. EPA is an essential fatty acid, which can be metabolized to DHA and is a component of the human diet if fish is consumed. Aripiprazole is a novel second general antipsychotic that seems to function as a partial agonist at the dopamine D2 and serotonin 5-HT 1A receptors as well as an antagonist at the serotonin 5-HT 2A receptor. Since it has a favorable adverse event profile in adults, it is an attractive choice for the treatment of youth with bipolar disorder if proven efficacious. Although pilot research showed that omega-3 fatty acids monotherapy treatment resulted in improvement of manic symptoms, the improvement is less dramatic than that observed in trials of antipsychotics. We will test the safety and efficacy of omega-3 fatty acids versus placebo as an adjunctive treatment to open-label aripiprazole in children and adolescents with bipolar disorder.
The proposed study includes 1) the use of a 12-week design to document the response rate 2) careful assessment of safety and tolerability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole plus Fish Oil | Active Comparator | Subjects administered aripiprazole and randomized to receive fish oil |
|
| Aripiprazole plus Placebo | Placebo Comparator | Subjects administered aripiprazole and randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS) | The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60. | weekly for 1st 6 weeks then biweekly |
| Measure | Description | Time Frame |
|---|---|---|
| DSM-IV Mania Symptom Checklist | The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0. | weekly for first 6 weeks then biweekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Wozniak, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole + Fish Oil | treatment with aripiprazole + fish oil |
| FG001 | Aripiprazole + Placebo | treatment with aripiprazole + placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole + Fish Oil | treatment with aripiprazole + fish oil |
| BG001 | Aripiprazole + Placebo | treatment with aripiprazole + placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS) | The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60. | 14 subjects came in for week 12 assessments - included in final analysis. | Posted | Mean | Standard Deviation | Units on a scale | weekly for 1st 6 weeks then biweekly |
|
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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 + Fish Oil | treatment with aripiprazole + fish oil |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest pain with inspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Wozniak, MD | Massachusetts General Hospital | 617-503-1038 | jwozniak@partners.org |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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|
| fish oil | Dietary Supplement | 1600mg (4 capsules) daily for 12 weeks |
|
| Placebo | Drug | Placebo |
|
| Adverse Event |
|
| Protocol Violation |
|
| Study drug expired |
|
| Other |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | DSM-IV Mania Symptom Checklist | The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0. | 14 subjects came in for week 12 assessments - included in final analysis. | Posted | Mean | Standard Deviation | units on a scale | weekly for first 6 weeks then biweekly |
|
|
|
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Aripiprazole + Placebo | treatment with aripiprazole + placebo | 0 | 10 | 9 | 10 |
| cold symptoms | General disorders | Non-systematic Assessment |
|
| decreased energy | General disorders | Non-systematic Assessment |
|
| decreased appetite | General disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| dry mouth | General disorders | Non-systematic Assessment |
|
| ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
|
| flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| hand tremor | General disorders | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| increased appetite | General disorders | Non-systematic Assessment |
|
| increased sleep | General disorders | Non-systematic Assessment |
|
| irritability | General disorders | Non-systematic Assessment |
|
| left ankle swelling (injury) | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| period 1 week late | Reproductive system and breast disorders | Non-systematic Assessment |
|
| nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| rash (poison ivy) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| restless | General disorders | Non-systematic Assessment |
|
| rhinorrhea | General disorders | Non-systematic Assessment |
|
| saddness/crying | Psychiatric disorders | Non-systematic Assessment |
|
| sedation | General disorders | Non-systematic Assessment |
|
| skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| slurred speech | General disorders | Non-systematic Assessment |
|
| sore throat | General disorders | Non-systematic Assessment |
|
| sores in mouth (healed) | General disorders | Non-systematic Assessment |
|
| sprained finger | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| stomachache | Gastrointestinal disorders | Non-systematic Assessment |
|
| tiredness | General disorders | Non-systematic Assessment |
|
| transient facial flushing | General disorders | Non-systematic Assessment |
|
| weight gain | General disorders | Non-systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009821 | Oils |
| D008055 | Lipids |