SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia (NSS)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Negative Symptoms of Schizophrenia
• Intervention / Treatment: Drug: SPD489 Low-Dose; Drug: SPD489 High-Dose; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo capsule taken once-daily for up to 26 weeks
Experimental: SPD489 Low-Dose	Drug: SPD489 Low-Dose; SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks; Other Names: Vyvanse, Lisdexamfetamine dimesylate, LDX
Experimental: SPD489 High-Dose	Drug: SPD489 High-Dose; SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks; Other Names: Vyvanse, Lisdexamfetamine dimesylate, LDX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Negative Symptom Assessment (NSA-16) total score	up to 26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Positive and Negative Syndrome Scale (PANSS)	up to 26 weeks

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Anticipated): January 27, 2012
• Primary Completion (Anticipated): February 24, 2014
• Study Completion (Anticipated): February 24, 2014

Study Registration Dates

• First Submitted: October 29, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 4, 2010

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: SPD489-320