SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/30/2013 |
| Start Date: | February 2013 |
| End Date: | November 2014 |
| Contact: | Shire Call Center |
| Phone: | 1-800-842-5335 |
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 160mg) as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
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.
Inclusion Criteria:
- - 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
Exclusion Criteria:
- 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
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