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Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

NCT01738698 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-06-22

Study results available
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Summary

The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).

Conditions

Interventions

DRUG

SPD489 40mg

Oral administration of 40 mg once-daily for up to 12 weeks

DRUG

SPD489 100mg

Oral administration of 100 mg once-daily for up to 12 weeks

DRUG

SPD489 160mg

Oral administration of 160 mg once-daily for up to 12 weeks

DRUG

Placebo

Oral administration once-daily for 12 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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-01
Primary Completion
2013-04-01
Completion
2013-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01738698 on ClinicalTrials.gov