Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia
NCT ID: NCT01738698
Last Updated: 2021-06-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
4 participants
INTERVENTIONAL
2012-11-01
2013-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SPD489 40mg
SPD489 40mg
Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg
SPD489 100mg
Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg
SPD489 160mg
Oral administration of 160 mg once-daily for up to 12 weeks
Placebo
Placebo
Oral administration once-daily for 12 weeks
Interventions
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SPD489 40mg
Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg
Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg
Oral administration of 160 mg once-daily for up to 12 weeks
Placebo
Oral administration once-daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \>4 hours/week with the subject)
* Fixed home/place of residence and can be reached by telephone
* On a stable dose of antipsychotic medications
* Able to swallow capsules
Exclusion Criteria
* Treated with clozapine in past 30 days
* Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
* History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
* Uncontrolled hypertension
* History of thyroid disorder that has not been stabilized on thyroid medication
* Glaucoma
* Pregnant or nursing
* Subject has received an investigational product or participated in a clinical study within 30 day
18 Years
65 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University Hills Clinical Research
Irving, Texas, United States
Countries
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Other Identifiers
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2012-003918-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-338
Identifier Type: -
Identifier Source: org_study_id
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