We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00423943
First Posted: January 18, 2007
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Minzenberg, MD, University of California, Davis
Results First Submitted: January 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: modafinil
Drug: Placebos

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Drug

modafinil

modafinil: 200 milligrams daily dose

Placebo

placebo

modafinil: 200 milligrams daily dose


Participant Flow:   Overall Study
    Drug   Placebo
STARTED   19   14 
COMPLETED   16   13 
NOT COMPLETED   3   1 
Withdrawal by Subject                3                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Drug

modafinil

modafinil: 200 milligrams daily dose

Placebo

placebo

modafinil: 200 milligrams daily dose

Total Total of all reporting groups

Baseline Measures
   Drug   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   14   33 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      19 100.0%      14 100.0%      33 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.4  (7.7)   25.8  (8.9)   26.2  (8.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  21.1%      3  21.4%      7  21.2% 
Male      15  78.9%      11  78.6%      26  78.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4  21.1%      0   0.0%      4  12.1% 
Not Hispanic or Latino      15  78.9%      14 100.0%      29  87.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   5.3%      4  28.6%      5  15.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   5.3%      3  21.4%      4  12.1% 
White      17  89.5%      7  50.0%      24  72.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   19   14   33 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Accuracy on High-control (i.e., Difficult) Condition of Preparing to Overcome Prepotency Task   [ Time Frame: Baseline, 4 weeks ]

2.  Primary:   Control-related BOLD Signal Change in Locus Coeruleus   [ Time Frame: 4 weeks ]

3.  Primary:   Gamma Power Change in Count of Clusters   [ Time Frame: 4 weeks ]

4.  Secondary:   Change in Positive Symptoms   [ Time Frame: Baseline, 4 weeks ]

5.  Secondary:   Change in Negative Symptoms   [ Time Frame: Baseline, 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Michael Minzenberg
Organization: University of California, Los Angeles
phone: 310-825-7642
e-mail: MMinzenberg@mednet.ucla.edu



Responsible Party: Michael Minzenberg, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00423943     History of Changes
Other Study ID Numbers: 200513585-1
First Submitted: January 16, 2007
First Posted: January 18, 2007
Results First Submitted: January 18, 2017
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017