MedTrace Logo

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

NCT00922272 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2021-06-09

Study results available
· View outcomes & findings →

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

DRUG

SPD489 (lisdexamfetamine dimesylate)

oral, 20, 30, 40, 50, 60, or 70 mg once daily

DRUG

Placebo matching SPD489 (lisdexamfetamine dimesylate)

oral, once daily

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-14
Primary Completion
2011-01-20
Completion
2011-01-20

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00922272 on ClinicalTrials.gov