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Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

NCT01760993 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-06-22

Study results available
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Summary

The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Conditions

Interventions

DRUG

SPD489

Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2013-04-01
Completion
2013-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01760993 on ClinicalTrials.gov