Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/30/2013 |
| Start Date: | November 2012 |
| End Date: | January 2015 |
| Contact: | Shire Call Center |
| Phone: | 1-866-842-5335 |
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 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 40 mg, 100 mg, and 160 mg
are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).
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 day
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