N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder
Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston