SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

Negative Symptoms of Schizophrenia Clinical Trial

— NSS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01234298
• Other study ID #: SPD489-320
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 27, 2012
• Est. completion date: February 24, 2014

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 24, 2014
• Est. primary completion date: February 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Negative Symptoms of Schizophrenia
• Schizophrenia

Intervention

Drug:
• SPD489 Low-Dose
SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
• SPD489 High-Dose
SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
• Placebo
Placebo capsule taken once-daily for up to 26 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative Symptom Assessment (NSA-16) total score		up to 26 weeks
Secondary	Positive and Negative Syndrome Scale (PANSS)		up to 26 weeks