NCT01488929

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

A Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Assess Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 603 (actual)
• Sponsor: Targacept Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Schizophrenia
• Negative Symptoms
• Cognitive Dysfunction

Interventions

Type	Name	Description
DRUG	TC-5619
DRUG	Placebo

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-12-08
• Last updated: 2015-06-03

Locations

64 sites across 6 countries: United States, Hungary, Romania, Russia, Serbia, Ukraine