NCT00922272

Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms

A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).

Conditions

• Schizophrenia and Predominant Negative Symptoms

Interventions

Type	Name	Description
DRUG	SPD489 (lisdexamfetamine dimesylate)	oral, 20, 30, 40, 50, 60, or 70 mg once daily
DRUG	Placebo matching SPD489 (lisdexamfetamine dimesylate)	oral, once daily

Timeline

• Start date: 2009-09-14
• Primary completion: 2011-01-20
• Completion: 2011-01-20
• First posted: 2009-06-17
• Last updated: 2021-06-09
• Results posted: 2012-02-20

Locations

27 sites across 1 country: United States