Phase 4
N=29
Modafinil Effects on Cognition in Schizophrenia Patients
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00711464 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Cognitive Performance — 76.7; 75.5; 67.2; 77.1 percentage correct of all trials
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- modafinil (M1, M2, M4) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Performance |
76.7; 75.5; 67.2; 77.1 | — |
| SECONDARY Systolic Blood Pressure |
109; 112; 116; 111 | — |
| SECONDARY Heart Rate |
74; 81; 86; 76 | — |
Summary
Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This includes many types of cognitive dysfunction, such as in attention, memory and language. These problems may explain why patients with schizophrenia think and act in unusual ways, and often have problems managing aspects of their lives that healthy adults take for granted. Unfortunately, the biochemical aspects of these dysfunctions are presently unknown, and it is not clear whether current psychiatric medications can improve these functions. A recent FDA-approved medication that may improve this function is modafinil. Studies in animals and healthy adults show that this medication can improve many of these cognitive functions. We plan to study the effects of modafinil on these cognitive processes, by giving various doses of this medication to patients before they perform tasks of these cognitive processes. We predict that when patients receive modafinil, they will perform better on a cognitive test, and that these benefits will depend on the dose given.
Eligibility Criteria
Inclusion Criteria
- adults age 18-54
- diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
- able to provide informed consent
Exclusion Criteria
- history of significant head injury or other neurological illness
- active psychiatric illness requiring significant acute care
- significant intellectual impairment (e.g. standardized full-scale IQ < 70)
- history of medical illness or treatment that is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
- significant active substance abuse
- active pregnancy
- active treatment with medications that have drug interactions with modafinil
Data sourced from ClinicalTrials.gov (NCT00711464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.