NCT01234298

SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 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• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.

Conditions

• Negative Symptoms of Schizophrenia

Interventions

Type	Name	Description
DRUG	SPD489 Low-Dose	SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
DRUG	SPD489 High-Dose	SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
DRUG	Placebo	Placebo capsule taken once-daily for up to 26 weeks

Timeline

• Start date: 2012-01-27
• Primary completion: 2014-02-24
• Completion: 2014-02-24
• First posted: 2010-11-04
• Last updated: 2021-06-03