NCT01738698

Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 160mg as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SPD489 40mg	Oral administration of 40 mg once-daily for up to 12 weeks
DRUG	SPD489 100mg	Oral administration of 100 mg once-daily for up to 12 weeks
DRUG	SPD489 160mg	Oral administration of 160 mg once-daily for up to 12 weeks
DRUG	Placebo	Oral administration once-daily for 12 weeks

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-11-30
• Last updated: 2021-06-22
• Results posted: 2014-05-29

Locations

1 site across 1 country: United States