Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant 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 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).
Key facts
- Study ID
- NCT01738698
- Run by
- Shire
- People needed
- 4
- Starts
- 2012-11-01
- 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 day
Where it is running
- University Hills Clinical Research — Irving, Texas, United States
Full record on ClinicalTrials.gov
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