Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

NCT ID: NCT01658150

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2018-01-02

Brief 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.

Detailed Description

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

isradipine

open label

Group Type: EXPERIMENTAL

isradipine

Intervention Type: DRUG

Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel

Interventions

isradipine

Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel

Intervention Type: DRUG

Other Intervention Names

Dynacirc CR

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Katherine Burdick

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Burdick, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSM# 12-00311

Identifier Type: -

Identifier Source: secondary_id

GCO 12-0679

Identifier Type: -

Identifier Source: org_study_id