Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

NCT01658150 | Completed Results

• 2 other identifiers: GCO 12-0679HSM# 12-00311
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Cognition; Schizophrenia; Schizoaffective disorder

Outcome Measures

Primary Outcomes (3)

• MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures

  MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. A t score is a type of standard score computed by multiplying a z-score (how many standard deviations an element is from the mean) by 10 and adding 50.

  baseline and week 4

• UPSA Communication Score

  UCSD Performance Skills Assessment (UPSA) - The UPSA is performance-based measure of real-world daily functioning abilities. Participants receive scores for the communication subscale (range = 0-20), with higher score indicating better neurocognitive functioning

  baseline and week 4

• Quality of Life (QoL) Scale

  The QoL is a measure of the perceived satisfaction in an individual's daily life. This 16-item self-report measure is rated on a 7-point scale, ranging from 1 (terrible) to 7 (delighted), with a total score range from 16-112, where higher scores indicate higher satisfaction with daily life.

  baseline and Week 4

Secondary Outcomes (14)

• Mean Change in PRISE Adverse Event Checklist Score

  up to 4 weeks

• Number of Participants With Normal ECG

  baseline and week 4

• Number of Participants With Normal Chemistry Panel

  baseline and week 4

• Number of Participants With Normal Complete Blood Count (CBC)

  baseline and week 4

• Abnormal Involuntary Movement Scale (AIMS)

  baseline and Week 4

Study Arms (1)

isradipine

EXPERIMENTAL

open label

Drug: isradipine

Interventions

isradipine DRUG

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

Also known as: Dynacirc CR

isradipine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Isradipine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Katherine Burdick
• Organization: Icahn School of Medicine at Mount Sinia

katherine.burdick@mssm.edu

212-659-8841

Study Officials

• Katherine Burdick, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: August 6, 2012
• Study Start: September 1, 2012
• Primary Completion: January 2, 2018
• Study Completion: January 2, 2018
• Last Updated: December 5, 2018
• Results First Posted: December 5, 2018

Record last verified: 2018-11

Locations

US (1)