Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Icahn School of Medicine at Mount Sinai
With
Brain & Behavior Research Foundation
The purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder. Incomplete treatment response can be common in these disorders. While there are medications that are effective at treating positive symptoms, some other symptoms of the disorders are often left only partially treated (cognitive impairment and negative symptoms). This study will begin to address if the medication isradipine might help to treat some of the cognitive problems associated with schizophrenia and schizoaffective disorder. Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. It is currently approved by the FDA for hypertension.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18-60
DSM-IV schizophrenia or schizoaffective disorder diagnosis
Residual phase of illness criteria met at screen and baseline as defined by item scores of equal to or less than 4 on each of the Brief Psychiatric Rating Scale (BPRS) hallucinatory behavior, unusual thought content, conceptual disorganization items
Hamilton Rating Scale for Depression (HRSD) equal to or less than 12
Baseline Clinician Administered Scale for Mania (CARS-M) score of less than 5
Simpson Angus Scale (SAS) total score equal to or less than 6
Treatment with at least one but no more than two stably-dosed second-generation antipsychotic medication (other than clozapine) for equal to or greater than 2 months and no changes planned over the 4-week study period
You may not be if
History of CNS trauma, neurological disorder, ADHD, mental retardation, learning disability, or other non-schizophrenic cause of cognitive impairment
DSM-IV diagnosis of substance abuse/dependence within 3 months
Pregnant women or women of childbearing age who are not using a medically accepted means of contraception
Women who are breastfeeding
Active, unstable medical problem that may interfere with cognition
Current treatment for hypertension
Uncontrolled hypertension
Any drug known to interact with isradipine
History of GI strictures
History of heart disease
Abnormal lab or ECG at screen
Significant suicidal ideation at baseline (HRSD item 3\>2)
