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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01234298
Other study ID # SPD489-320
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date January 27, 2012
Est. completion date February 24, 2014

Study information

Verified date May 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 24, 2014
Est. primary completion date February 24, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
SPD489 Low-Dose
SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
SPD489 High-Dose
SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
Placebo
Placebo capsule taken once-daily for up to 26 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shire

Outcome

Type Measure Description Time frame Safety issue
Primary Negative Symptom Assessment (NSA-16) total score up to 26 weeks
Secondary Positive and Negative Syndrome Scale (PANSS) up to 26 weeks
See also
  Status Clinical Trial Phase
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Completed NCT03397134 - Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia Phase 3
Recruiting NCT04620460 - Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia N/A