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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01797575
The ClinicalTrials.gov registry entry for NCT01797575 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Aspirin is the first listed.
NCT01797575 reports 0 study locations.
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.
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