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NCT01488929 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
A Phase 2 study of Schizophrenia and Cognitive Dysfunction, sponsored by Targacept.
- Completed
- Registry status
- Phase 2
- Development phase
- 603
- Enrollment target
- 20
- Study locations
NCT01488929 is a Phase 2 study of Schizophrenia and Cognitive Dysfunction that has completed, run by Targacept. The registered enrollment target is 603 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (178% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT01488929, a Phase 2 study of Schizophrenia and Cognitive Dysfunction, has completed, sponsored by Targacept.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 603 participants
- Enrollment target
- 20
- Study locations
Study Summary
Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on the function, employment, and social interactions of patients with schizophrenia. Medications used to treat schizophrenia (e.g. atypical antipsychotics) do not improve negative symptoms or CDS. TC-5619 is being developed for use as an add-on therapy in combination with atypical antipsychotics to treat patients with negative symptoms and CDS.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TC-5619
Study Locations (20)
California
- Collaborative Neuroscience Network, Inc - Garden Grove
- Behavorial Research Specialists - Glendale
- Apostle Clinical Trials, Inc - Long Beach
- Synergy Clinical Research Center - National City
- Excell Research, Inc. - Oceanside
- Neuropsychiatric Research Center of Orange County - Orange
- CNRI - San Diego
Florida
- Segal Institute for Clinical Research - Lauderhill
- Compass Research, LLC - Leesburg
Missouri
- St. Charles Psychiatric Associates - Midwest Reserch Group - Saint Charles
- PsychCare Consultants Research - St Louis
New York
- Behavioral Medical Research - Brooklyn
- Finger Lakes Clinical Research - Rochester
Ohio
- Neuro-Behavorial Clinic Research, Inc. - Canton
- Midwest Clinical Research Center - Dayton
Georgia
- Atlanta Center for Medical Research - Atlanta
Illinois
- Alexian Brothers Behavioral Health Hospital - Hoffman Estates
Mississippi
- Precise Research Group - Flowood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 603 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01488929
The ClinicalTrials.gov registry entry for NCT01488929 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 603 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (178% higher). The listed sponsor is Targacept, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01488929 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT01488929 about?
NCT01488929 is a clinical study titled "Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia". Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on the function, employment, and social interactions of patients with schizophrenia. Medications used to treat schizophrenia...
What is the current status of trial NCT01488929?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 603 participants. The study started on 2011-12. Estimated completion is 2013-11.
What conditions does trial NCT01488929 study?
This clinical trial studies the following conditions: Schizophrenia, Cognitive Dysfunction, Negative Symptoms.
What interventions are being tested in trial NCT01488929?
The interventions under investigation include: Placebo (DRUG), TC-5619 (DRUG).
Who is sponsoring clinical trial NCT01488929?
This trial is sponsored by Targacept, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01488929 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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