NCT01760889

SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 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: 1 (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 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SPD489 low dose range (40mg, 80mg, and 100mg)	Capsule, dose titration, * 40 mg capsule once-daily for 1 week; then * 80 mg capsule once-daily for 4 weeks; then, * 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; * if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks
DRUG	SPD489 high dose range (120mg, 140mg and 160mg)	Capsule, dose titration, * 40 mg capsule once-daily for 1 week; then * 80 mg capsule once daily for 1 week; then * 120 mg capsule once-daily for 1 week, then, * 140 mg capsule once-daily for 2 weeks, then * 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; * if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
DRUG	Placebo	One capsule a day for 26 weeks

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2013-01-04
• Last updated: 2021-06-22
• Results posted: 2014-05-29

Locations

4 sites across 1 country: United States