SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Schizophrenia
In brief
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.
Key facts
- Study ID
- NCT01760889
- Run by
- Shire
- People needed
- 1
- Starts
- 2013-02-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2021-06-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- - 18 to 65 years of age
- 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
You may not qualify if…
- Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
- 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 days
Where it is running
- Galiz Research — Miami Springs, Florida, United States
- Psychiatric Care and Research Center — O'Fallon, Missouri, United States
- St. Charles Psychiatric Associates — Saint Charles, Missouri, United States
- CRI Lifetree — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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