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COMPLETED Phase 2

Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia

NCT01488929 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 603 participants
Start Date 2011-12
Est. Completion 2013-11
Phase Phase 2

Sponsor

Targacept

5 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 603 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Targacept, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01488929 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01488929?

The interventions under investigation include: Placebo (DRUG), TC-5619 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01488929?

This trial is sponsored by Targacept, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial