DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Negative Symptoms of Schizophrenia

Intervention: SPD489 Low-Dose (Drug); SPD489 High-Dose (Drug); Placebo (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Shire

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Negative Symptom Assessment (NSA-16) total score

Secondary outcome: Positive and Negative Syndrome Scale (PANSS)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: January 2012
Last updated: March 13, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017