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NCT01965925 · ClinicalTrials.gov registry record · Phase 4
Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT01965925: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01965925 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01965925, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar disorder patients. Results will provide information on a promising treatment for simultaneously treating both sleep and cognitive problems in stable bipolar patients. These disabling symptoms persist despite stable mood and are strongly associated with functional disability, making them important treatment targets that have not yet been adequately addressed.
Primary Outcome
Adverse events will be carefully measured and recorded in an effort to determine the base rates for common side effects in BD. Specifically, mood and psychosis ratings will be conducted.
Interventions
- DRUG Placebo
- DRUG Modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-01 |
| Est. Completion | 2017-11-09 |
| Phase | Phase 4 |
What the finished NCT01965925 record still lists
NCT01965925 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01965925 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01965925 about?
NCT01965925 is a clinical study titled "Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil". This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar disorder patients. Results will provide information on a promising treatment for simultaneously treating both sleep and cognitive problems in stable bipolar patients. These disabling symptoms persist despite stabl...
What is the current status of trial NCT01965925?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2014-01. Estimated completion is 2017-11-09.
What interventions are being tested in trial NCT01965925?
The interventions under investigation include: Placebo (DRUG), Modafinil (DRUG).
Who is sponsoring clinical trial NCT01965925?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01965925's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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