Status:
COMPLETED
Pharmacologic and Clinical Testing of a D1 Agonist for Cognitive Enhancement in Neuropsychiatric Disorders
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
The investigators propose to recruit individuals with schizophrenia who are symptomatically stable and already taking medications to participate in this study. The investigators will recruit 90 indivi...
Detailed Description
Schizophrenia (SCZ) manifests as positive symptoms, negative symptoms and cognitive disturbances. To date, all of the available medications to treat schizophrenia bind primarily to the dopamine-2 (D2)...
Eligibility Criteria
Inclusion
- Males or females between 18 and 55 years old
- Fulfill Diagnostic and Statistical Manual, version 4 (DSM-IV) criteria schizophrenic illness, schizophreniform or schizoaffective disorder
- A negative urine toxicology
- Capacity to understand the study and to give written informed consent
- Must be on a stable dose of risperidone, aripiprazole, lurasidone, iloperidone, paliperidone, or haloperidol for at least 4 weeks if oral adn 2 cycles if depot. Absence of any antipsychotic medications other than risperidone, aripiprazole, or haloperidol for at least 4 weeks if oral or 2 cycles if depot prior to the study. Mood stabilizers, benzodiazepines and antidepressants are allowed as long as the drugs have not been changed for 4 weeks.
- Psychiatrically stable
Exclusion
- Pregnancy or lactation, lack of effective birth control during the 15 days before the initial day of the study and for the duration of the drug trial
- Presence or positive history of severe medical or neurological illness, or any cardiovascular or liver disease
- Any current use of amphetamines, opiates, cocaine, sedative-hypnotics, cannabis, or other psychoactive drugs (other than nicotine)
- Metal implants or paramagnetic objects contained within the body which may interfere with MRI scan
- A history of substance dependence (other than nicotine or cannabis) or substance abuse within the previous 6 months (other than nicotine)
- Any current use of anticholinergic or anticoagulant medications. Any current use of any medications that can affect cognition or clotting other than occasional nonsteroidal antiinflammatory drug (NSAID)
- Impaired intellectual functioning
- Orthostatic hypotension
- BP systolic BP \<90 or \> 140 or diastolic BP \< 60 or \> 90
- Antipsychotic polypharmacy within the previous four weeks.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01519557
Start Date
April 1 2011
End Date
November 1 2013
Last Update
March 4 2015
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032