Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
First received: July 6, 2005
Last updated: June 6, 2014
Last verified: March 2013
Results First Received: January 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Interventions: Drug: Modafinil
Drug: Placebo

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Modafinil Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
Placebo Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
Total Total of all reporting groups

Baseline Measures
    Modafinil     Placebo     Total  
Number of Participants  
[units: participants]
  62     53     115  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     60     53     113  
>=65 years     2     0     2  
[units: years]
Mean (Standard Deviation)
  45.94  (9.35)     45.74  (8.57)     45.84  (8.96)  
[units: participants]
Female     8     7     15  
Male     54     46     100  
Region of Enrollment  
[units: participants]
United States     62     53     115  

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Fatigue Severity Scale (FSS)   [ Time Frame: Measured at baseline and Week 4 ]

2.  Primary:   Role Function Scale Outcome   [ Time Frame: Measured at baseline and Week 4 ]

3.  Secondary:   CD4 Cell Count   [ Time Frame: Measured at baseline and Week 4 ]

4.  Secondary:   HIV RNA Viral Load   [ Time Frame: Measured at baseline and Week 4 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was conducted at a single site in an urban setting where most patients have good access to medical care. Women were under-represented despite outreach efforts.

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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Judith Rabkin
Organization: New York State Psychiatric Institute
phone: 212.543.5762
e-mail: jgr1@columbia.edu

Publications of Results:
Other Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00118378     History of Changes
Other Study ID Numbers: #4839
R01MH072383-01 ( US NIH Grant/Contract Award Number )
Study First Received: July 6, 2005
Results First Received: January 3, 2012
Last Updated: June 6, 2014
Health Authority: United States: Federal Government