SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

Phase 3

Withdrawn

• Conditions: Negative Symptoms of Schizophrenia
• Interventions: Drug: SPD489 High-Dose; Drug: Placebo; Drug: SPD489 Low-Dose

• Registration Number: NCT01234298
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-04
• Study Start: 2012-01-27
• Primary Completion: 2014-02-24
• Study Completion: 2014-02-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subject has diagnosis of schizophrenia for at least 2 years
• Subject has persistent predominant negative symptoms
• Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
• Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
• Subject has been clinically stable and is in the non-acute phase of illness

Exclusion Criteria

• Subject has clinically notable positive symptoms
• Subject is considered to be treatment refractory
• Subject has current history of substance abuse/dependance
• Subject is considered a suicide risk or risk to harm others

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPD489 High-Dose	SPD489 High-Dose	-
Placebo	Placebo	-
SPD489 Low-Dose	SPD489 Low-Dose	-

Primary Outcome Measures

Name	Time	Method
Negative Symptom Assessment (NSA-16) total score	up to 26 weeks

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)	up to 26 weeks