CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
modafinil +1 moredrug
Likely dose
modafinil 200 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00423943
NCT00423943Phase 4Completed

Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia

University of California, Los Angeles·interventional·Posted Jan 18, 2007·Updated Sep 29, 2017

In Brief

A Phase 4 clinical trial evaluating modafinil and Placebos for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This appears to be responsible for their difficulties in social and occupational functioning. One particular cognitive function that may be important for schizophrenia is called context processing. This refers to the ability to properly use information in the environment to guide thinking and behavior so that it is appropriate to the present circumstance. Problems with this function 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. This cognitive function depends on a region of the brain called the prefrontal cortex, which shows impaired function in schizophrenia as well. Unfortunately, the biochemical aspects of this dysfunction are presently unknown, and it is not clear whether current psychiatric medications can improve this function. A recent FDA-approved medication that may improve this function is modafinil. Studies in animals and healthy adults show that this medication can improve cognitive functions which are related to context processing. We plan to study the effects of modafinil on context processing and the brain activity that underlies this function. We will use functional MRI and electrophysiology to examine the effects of modafinil, both after a single dose and after sustained (4 week) treatment. We predict that when patients receive modafinil they will perform better on cognitive tests and have improved activity in the regions of the brain that are responsible for these cognitive processes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2007
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 19.5 years ago

Interventions

modafinildrug

200 milligrams daily dose

Placebosdrug

capsule containing placebo