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Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

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ClinicalTrials.gov Identifier: NCT01658150
Recruitment Status : Recruiting
First Posted : August 6, 2012
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Katherine Burdick, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment
Schizophrenia Schizoaffective Disorder Drug: isradipine

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Molecular Approach to Treat Cognition in Schizophrenia: Ca2+ Channel Blockade
Study Start Date : September 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Isradipine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in Neurocognitive/Functional Measures [ Time Frame: baseline and week 4 ]
    MATRICS Consensus Cognitive Battery (MCCB), UCSD Performance Skills Assessment (UPSA), Quality of Life Scale (QoL)compared at week 4 to baseline


Secondary Outcome Measures :
  1. Side Effects Checklist (SEC) and side effect self-report form [ Time Frame: up to 4 weeks ]
    Side Effects Checklist (SEC) and side effect self-report form

  2. Change in ECG [ Time Frame: baseline and week 4 ]
    ECG to confirm inclusion into study and compared at week 4 to baseline

  3. Change in chemistry panel [ Time Frame: baseline and week 4 ]
    to confirm inclusion into study and change in chemistry panel compared at week 4 to baseline

  4. Change in complete blood count (CBC) [ Time Frame: baseline and week 4 ]
    to confirm inclusion into study and change in CBC compared at week 4 to baseline

  5. Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: up to 4 weeks ]
    to monitor abnormal involuntary movement throughout the study

  6. Simpson Angus Scale (SAS) [ Time Frame: up to 4 weeks ]
    to monitor extrapyramidal side effects throughout the study

  7. Beck Scale for Suicidal Ideation (SSI) [ Time Frame: up to 4 weeks ]
    to monitor suicidal ideation throughout the study

  8. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: up to 4 weeks ]
    to monitor suicidal ideation throughout the study

  9. Structured Clinical Interview for the DSM-IV (SCID-IV) [ Time Frame: baseline ]
    to confirm diagnosis for inclusion into study

  10. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: up to 4 weeks ]
    to monitor psychiatric symptoms throughout the study

  11. Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: up to 4 weeks ]
    to monitor negative symptoms throughout the study

  12. Hamilton Rating Scale for Depression (HRSD) [ Time Frame: up to 4 weeks ]
    to monitor symptoms of depression throughout the study

  13. Clinical Global Impression Scale (CGI) [ Time Frame: up to 4 weeks ]
    to monitor psychiatric illness severity throughout the study

  14. Clinician Administered Rating Scale for Mania (CARS-M) [ Time Frame: up to 4 weeks ]
    to monitor symptoms of mania throughout the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658150


Contacts
Contact: Emmett Larsen 212-659-9683 emmett.larsen@mssm.edu
Contact: Megan Shanahan, MHS 212-659-8874 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: Emmett Larsen    212-659-9683    emmett.larsen@mssm.edu   
Contact: Megan Shanahan, MHS    212-659-8874    megan.shanahan@mssm.edu   
Principal Investigator: Katherine Burdick, PhD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Brain & Behavior Research Foundation
Investigators
Principal Investigator: Katherine Burdick, PhD Icahn School of Medicine at Mount Sinai

Responsible Party: Katherine Burdick, Principal Investigator, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01658150     History of Changes
Other Study ID Numbers: GCO 12-0679
HSM# 12-00311
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Katherine Burdick, Icahn School of Medicine at Mount Sinai:
Cognition
Schizophrenia
Schizoaffective disorder

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Isradipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents