depression on %): exhaustion (1), CDSS (A):53 (P) psychotic -current suicidal 39 disorder (1), ideation or suicidal ideation previous (1) suicide attempt -moderate or worse CDSS suicide ítems score (≥2) -homicidal ideation or aggression psychotic episode -exacerbation of illness -substance abuse or dependence within 6 mos -seizure disorder -clinically significant brain surgery/trauma -ECT -tardive dyskinesia -any significant movement disorder Rabkin JG et Inclusion: -50 mg Age: (A) NR= 70 Adverse events Armodafinil appears safe al. -HIV + 46 more frequent and effective for patients - 21-70 years of (P) 46 vs placebo at with clinically significant age -Titrate Male %:(A) week 4: fatigue associated with 2011;52: -Clinically by 50 86 (P) 88 Headache HIV. No significant 75 % receiving 328-336 significant mg White A: 19% P: 6% (p= changes were noted in armodafinil were fatigued weekly Race%: 0.09) regards to depressive responders 4 week interfering with until (A) 47 (P) symptoms or changes in (CGI-C of 1 or 2) R, DB, PC 2daily effect, 50 Discontinuation CD4/ Viral load. ≥ vs 26% placebo activities on a max DSM-IV due to (p <0.0001) + 26 RFS 250 tolerability: Single-center study limits, (NNT=2) at open label -≥41 on a FSS mg. A: 1 P: 2 small sample size, and week 4 exclusion criteria Exclusion: -Placebo %: 1 patient - Change in -Significant antivirals/ (A) 39 (P) discontinued at improvements in end of 4 weeks ESS, RFS, and ESS: due to feeling CFS -Unstable/ (A) 14.6 (P) “hyper” 14.0 untreated -Adjusted HRSD conditions and BDI not including significantly depresison or improved conditions that may contribute to fatigue -Current/recent substance use disorder
%): (A):53 (P) 39 exhaustion (1), psychotic disorder (1), suicidal ideation (1) depression on CDSS -current suicidal ideation or previous suicide attempt -moderate or worse CDSS suicide ítems score (≥2) -homicidal ideation or aggression psychotic episode -exacerbation of illness -substance abuse or dependence within 6 mos -seizure disorder -clinically significant brain surgery/trauma -ECT -tardive dyskinesia -any significant movement disorder Rabkin JG et al. 2011;52: 328-336 4 week R, DB, PC + 26 open label Inclusion: -HIV + - 21-70 years of age -Clinically significant fatigued interfering with ≥ 2daily activities on a RFS -≥41 on a FSS -50 mg -Titrate by 50 mg weekly until effect, max 250 mg. -Placebo Age: (A) 46 (P) 46 Male %:(A) 86 (P) 88 White Race%: (A) 47 (P) 50 DSM-IV %: (A) 39 (P) ESS: (A) 14.6 (P) 14.0 NR= 70 75 % receiving armodafinil were responders (CGI-C of 1 or 2) vs 26% placebo (p <0.0001) (NNT=2) at week 4 -Significant improvements in ESS, RFS, and CFS -Adjusted HRSD and BDI not significantly improved Adverse events more frequent vs placebo at week 4: Headache A: 19% P: 6% (p= 0.09) Discontinuation due to tolerability: A: 1 P: 2 1 patient discontinued at end of 4 weeks due to feeling “hyper” Armodafinil appears safe and effective for patients with clinically significant fatigue associated with HIV. No significant changes were noted in regards to depressive symptoms or changes in CD4/ Viral load. Single-center study limits, small sample size, and exclusion criteria Exclusion: - Change in antivirals/ -Unstable/ untreated conditions including depresison or conditions that may contribute to fatigue -Current/recent substance use disorder
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