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NCT01003379 · ClinicalTrials.gov registry record · Phase 2
TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients With Cognitive Dysfunction in Schizophrenia
A Phase 2 study, sponsored by Targacept.
- Completed
- Registry status
- Phase 2
- Development phase
- 184
- Enrollment target
NCT01003379: Completed Phase 2 study, sponsored by Targacept.
NCT01003379 is a Phase 2 study that has completed, run by Targacept. The registered enrollment target is 184 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01003379, a Phase 2 study, has completed, sponsored by Targacept.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 184 participants
- Enrollment target
Study Summary
Schizophrenia affects approximately 1% of the population worldwide, and in about 80% of cases, it is a lifelong, disabling illness. It is a multi-dimensional disease that is associated with symptoms that have been characterized as positive, negative, and cognitive. CDS is a core feature of schizophrenia, and most individuals with schizophrenia exhibit cognitive impairment. Attention disorders, slow information processing, working memory disorders, and lack of flexibility for adaptive strategies are symptoms of cognitive impairment that have a devastating impact on the function, employment, and social status of patients with schizophrenia. Older typical neuroleptic medications (e.g., haloperidol, fluphenazine) do not improve cognition. In fact, haloperidol has been shown to induce cognitive impairment in schizophrenic patients. Novel atypical antipsychotics, such as risperidone, clozapine, and olanzapine, seem to produce gains in cognition. This improvement may reflect a diminution of extrapyramidal side effects of the typical high potency neuroleptics. Alternatively, it might reflect more effective symptom reduction by the novel antipsychotics, or direct cognitive enhancement through the effects of the newer agents on a variety of neurotransmitters, their receptors, and gene expression. Even when the newer antipsychotic medications improve cognition, they do not normalize it. Presently, there are no approved therapies for CDS. However, in schizophrenic patients, nicotine improves multiple cognitive domains, including working memory and attention. Furthermore, based on a strong body of evidence ranging from genetic mapping to clinical trials, the alpha7 NNR subtype has emerged as a primary therapeutic target relevant to CDS and other core symptoms of schizophrenia
Interventions
- DRUG Placebo
- DRUG TC-5619
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT01003379 record still lists
NCT01003379 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01003379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01003379 about?
NCT01003379 is a clinical study titled "TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients With Cognitive Dysfunction in Schizophrenia". Schizophrenia affects approximately 1% of the population worldwide, and in about 80% of cases, it is a lifelong, disabling illness. It is a multi-dimensional disease that is associated with symptoms that have been characterized as positive, negative, and cognitive. CDS is a core feature of schizophr...
What is the current status of trial NCT01003379?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2009-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01003379?
The interventions under investigation include: Placebo (DRUG), TC-5619 (DRUG).
Who is sponsoring clinical trial NCT01003379?
This trial is sponsored by Targacept, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01003379's enrollment target sits among peer trials
184 360th of 2000 higher than 1,638 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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