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NCT00423943 · ClinicalTrials.gov registry record · Phase 4
Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia
A Phase 4 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT00423943: Completed Phase 4 study, sponsored by University of California, Los Angeles.
NCT00423943 is a Phase 4 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423943, a Phase 4 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
Accuracy change on high-control (i.e., difficult) condition of Preparing to Overcome Prepotency (POP) Task. For high-control condition (red-cue), subjects responded in the incongruent direction (eg, for a right-pointing arrow, press the left button, and vice versa). Increased values indicate improved performance.
Interventions
- DRUG Placebos
- DRUG modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2005-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT00423943 record still lists
NCT00423943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT00423943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00423943 about?
NCT00423943 is a clinical study titled "Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia". 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 ...
What is the current status of trial NCT00423943?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2005-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00423943?
The interventions under investigation include: Placebos (DRUG), modafinil (DRUG).
Who is sponsoring clinical trial NCT00423943?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00423943's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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