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NCT00592683 · ClinicalTrials.gov registry record · Phase 4
Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT00592683: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00592683 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00592683, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT fish oil
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00592683
The ClinicalTrials.gov registry entry for NCT00592683 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00592683 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00592683 about?
NCT00592683 is a clinical study titled "Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents". 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: Ome...
What is the current status of trial NCT00592683?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2007-12. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00592683?
The interventions under investigation include: Placebo (DRUG), fish oil (DIETARY_SUPPLEMENT), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00592683?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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