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NCT00719706 · ClinicalTrials.gov registry record · Phase 2
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder
A Phase 2 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00719706: Completed Phase 2 study, sponsored by Mclean Hospital.
NCT00719706 is a Phase 2 study that has completed, run by Mclean Hospital. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00719706, a Phase 2 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments.
Primary Outcome
Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.
Interventions
- DRUG Placebo
- DRUG acetyl-l-carnitine PLUS alpha-lipoic acide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00719706 record still lists
NCT00719706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00719706 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00719706 about?
NCT00719706 is a clinical study titled "The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder". The primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who di...
What is the current status of trial NCT00719706?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2008-08. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00719706?
The interventions under investigation include: Placebo (DRUG), acetyl-l-carnitine PLUS alpha-lipoic acide (DRUG).
Who is sponsoring clinical trial NCT00719706?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00719706's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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