Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

Completed · Not applicable

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT01658150

Run by

Icahn School of Medicine at Mount Sinai

People needed

11

Starts

2012-09-01

Expected to finish

2018-01-02

Last updated by the study team

2018-12-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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)
• ECT treatment within 12 months

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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