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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 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;   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 
Overall Participants Analyzed 
[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.

  More Information
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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

Publications of Results:
Other Publications:

Responsible Party: New York State Psychiatric Institute 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