Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
Summary
This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.
Timeline
- Start
- 2004-12
- Primary completion
- 2010-06
- Completion
- 2010-11
Outcome
Met primary endpoint
registry MEAN Modafinil: Week 4 FSS: 34 (Standard Deviation 5) units on a scale MEAN Placebo: Week 4 FSS: 43 (Standard Deviation 13) units on a scale NCT00118378 ↗
registry analysis (superiority or other test); Modafinil vs Placebo; p < 0.001; ANCOVA NCT00118378 ↗
registry MEAN Modafinil: Week 4 Role Function Scale: 22 (Standard Deviation 9) units on a scale MEAN Placebo: Week 4 Role Function Scale: 27 (Standard Deviation 11) units on a scale NCT00118378 ↗
registry analysis (superiority or other test); Modafinil vs Placebo; p <0.001; ANCOVA NCT00118378 ↗
Publications
- Background Rabkin JG, McElhiney MC, Rabkin R, Ferrando SJ. Modafinil treatment for fatigue in HIV+ patients: a pilot study. J Clin Psychiatry. 2004 Dec;65(12):1688-95. doi: 10.4088/jcp.v65n1215.
- Results Rabkin JG, McElhiney MC, Rabkin R, McGrath PJ. Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study. J Clin Psychiatry. 2010 Jun;71(6):707-15. doi: 10.4088/JCP.09m05171bro. Epub 2010 May 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Modafinil | Small molecule | 200 mg | — |