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SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

NCT01234298 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-06-03

No results posted yet for this study

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.

Conditions

  • Negative Symptoms of Schizophrenia

Interventions

DRUG

SPD489 Low-Dose

SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks

DRUG

SPD489 High-Dose

SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks

DRUG

Placebo

Placebo capsule taken once-daily for up to 26 weeks

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
2012-01-27
Primary Completion
2014-02-24
Completion
2014-02-24

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Entities

Drugs

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 NCT01234298 on ClinicalTrials.gov