Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

• Status: Completed
• Trial end date: 2018-01-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Brain & Behavior Research Foundation
• Treatments: Isradipine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• ECT treatment within 12 months