Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Katherine Burdick, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01658150
First received: July 12, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Drug: isradipine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Molecular Approach to Treat Cognition in Schizophrenia: Ca2+ Channel Blockade

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change in Neurocognitive/Functional Measures [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
    MATRICS Consensus Cognitive Battery (MCCB), UCSD Performance Skills Assessment (UPSA), Quality of Life Scale (QoL)compared at week 4 to baseline


Secondary Outcome Measures:
  • Side Effects Checklist (SEC) and side effect self-report form [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    Side Effects Checklist (SEC) and side effect self-report form

  • Change in ECG [ Time Frame: baseline and week 4 ] [ Designated as safety issue: Yes ]
    ECG to confirm inclusion into study and compared at week 4 to baseline

  • Change in chemistry panel [ Time Frame: baseline and week 4 ] [ Designated as safety issue: Yes ]
    to confirm inclusion into study and change in chemistry panel compared at week 4 to baseline

  • Change in complete blood count (CBC) [ Time Frame: baseline and week 4 ] [ Designated as safety issue: Yes ]
    to confirm inclusion into study and change in CBC compared at week 4 to baseline

  • Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor abnormal involuntary movement throughout the study

  • Simpson Angus Scale (SAS) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor extrapyramidal side effects throughout the study

  • Beck Scale for Suicidal Ideation (SSI) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor suicidal ideation throughout the study

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor suicidal ideation throughout the study

  • Structured Clinical Interview for the DSM-IV (SCID-IV) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    to confirm diagnosis for inclusion into study

  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor psychiatric symptoms throughout the study

  • Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor negative symptoms throughout the study

  • Hamilton Rating Scale for Depression (HRSD) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor symptoms of depression throughout the study

  • Clinical Global Impression Scale (CGI) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor psychiatric illness severity throughout the study

  • Clinician Administered Rating Scale for Mania (CARS-M) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
    to monitor symptoms of mania throughout the study


Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: isradipine
open label
Drug: isradipine
Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel
Other Name: Dynacirc CR

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658150

Contacts
Contact: Megan Shanahan, MHS 212-241-2494 megan.shanahan@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Megan Shanahan, MHS    212-241-2494    megan.shanahan@mssm.edu   
Contact: Katherine Burdick, PhD    212-659-8841    katherine.burdick@mssm.edu   
Principal Investigator: Katherine Burdick, PhD         
Sponsors and Collaborators
Katherine Burdick
Investigators
Principal Investigator: Katherine Burdick, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Katherine Burdick, Principal Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01658150     History of Changes
Other Study ID Numbers: GCO 12-0679, HSM# 12-00311
Study First Received: July 12, 2012
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Cognition
Schizophrenia
Schizoaffective disorder

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Isradipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on August 19, 2014