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NCT01797575 · ClinicalTrials.gov registry record · Phase 2
N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT01797575: Completed Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
NCT01797575 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01797575, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
We propose to conduct a double-blind placebo-controlled trial with a widely available and prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC, involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed episode currently. This will be the first controlled study to test the hypothesis that aspirin and NAC, by themselves or in combination, will be beneficial in treating depression in bipolar disorder patients and in promoting mood stabilization. Our study has the following Aims: Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III - Examine efficacy of combined treatment with aspirin and NAC looking for synergistic, potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible mediators or modulators in therapeutic response in the treatment of depression in patients with Bipolar Disorder.
Primary Outcome
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9.
Interventions
- DRUG Aspirin
- DRUG Sugar Pill
- DIETARY_SUPPLEMENT N-acetyl-cysteine (NAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 2 |
What the finished NCT01797575 record still lists
NCT01797575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which Aspirin is the first listed.
NCT01797575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01797575 about?
NCT01797575 is a clinical study titled "N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder". We propose to conduct a double-blind placebo-controlled trial with a widely available and prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC, involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed episode currently. This wil...
What is the current status of trial NCT01797575?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2013-01. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT01797575?
The interventions under investigation include: Aspirin (DRUG), Sugar Pill (DRUG), N-acetyl-cysteine (NAC) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01797575?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01797575's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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