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Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
isradipine
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Cognition, Schizophrenia, Schizoaffective disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

isradipine

Arm Description

open label

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Mean Change in PRISE Adverse Event Checklist Score
The PRISE is a physician-administered checklist of adverse events. PRISE contains 33 items, each defined by an adverse event. Each item is rated on a 3-point scale, ranging from 0 (not present) to 2 (distressing), with a total score range from 0-66, where higher scores indicate more adverse events. Mean change for adverse events at week 4 as compared to baseline
Number of Participants With Normal ECG
Number of participants with normal ECG readings to confirm inclusion into study and compared at week 4 to baseline
Number of Participants With Normal Chemistry Panel
Number of participants with normal chemistry panel to confirm inclusion into study at baseline and week
Number of Participants With Normal Complete Blood Count (CBC)
Number of participants with normal CBC to confirm inclusion into study at baseline and week 4
Abnormal Involuntary Movement Scale (AIMS)
Mean change for abnormal involuntary movements throughout the study. The AIMS is a physician-administered scale of abnormal involuntary movements. AIMS consists of 10 items, each defined by a series of movements. Each item is rated on a 5-point scale, ranging from 0 (not observed) to 4 (severe), with a total score range from 0-40, where higher scores indicate abnormal involuntary movements.
Modified Simpson Angus Scale (MSAS)
Mean change for drug-induced disordered movement throughout the study. The MSAS is a physician-administered scale of abnormal drug-induced movements. MSAS consists of 6 items, each defined by a series of movements. Each item is rated on a 5-point scale, ranging form 0 (not observed) to 4 (most severe), with a total range of 0-24, where higher scores indicate drug-induced disordered movement.
Beck Scale for Suicidal Ideation (SSI)
a 21-question multiple choice, self-report inventory that is used for measuring the severity of suicidal ideation. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe suicidal ideation symptoms.
Number of Participants With Suicidal Acknowledgments
Number of participants with Suicidal acknowledgements based on the Columbia Suicide Severity Rating Scales (C-SSRS) - Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).
Number of Participants With a Confirmed SCID-IV
Number of participants with confirm diagnosis for inclusion into study using the Structured Clinical Interview for the DSM-IV (SCID-IV)
Brief Psychiatric Rating Scale (BPRS)
Mean change for positive symptoms throughout the study. BPRS consists of 18 items, each defined by a series of symptoms. Each item is rated on a 7-point scale, ranging from 1 (not observed) to 7 (very severe), with a total score range from 18-126, where higher scores indicate psychiatric symptoms.
Scale for the Assessment of Negative Symptoms (SANS)
Mean change of negative symptoms throughout the study. SANS consists of 22 items, each defined by a series of symptoms. Each item is rated on a 6-point scale, ranging from 0 (no presence) to 5 (severe presence), with a total range of 0-110, where higher scores indicate negative symptoms.
Hamilton Rating Scale for Depression (HRSD)
Mean change of symptoms of depression throughout the study. HRSD consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where higher score indicates more depressive symptoms
Clinical Global Impression Scale (CGI)
Mean change of clinical impression of severity of psychiatric illness throughout the study. CGI consists of one item, defined by severity of illness. It is rated on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with a total range score of 1-7, where higher score indicates severity of illness.
Clinician Administered Rating Scale for Mania (CARS-M)
Mean change of symptoms of mania throughout the study. CARS-M contains 14 items rated from 0 (absent) to 5 (present) and one item scored 0 to 4, with total range from 0 to 74, where higher score indicates manic symptoms.

Full Information

First Posted
July 12, 2012
Last Updated
November 9, 2018
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Brain & Behavior Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01658150
Brief Title
Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder
Official Title
A Molecular Approach to Treat Cognition in Schizophrenia: Ca2+ Channel Blockade
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
January 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Brain & Behavior Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Cognition, Schizophrenia, Schizoaffective disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
isradipine
Arm Type
Experimental
Arm Description
open label
Intervention Type
Drug
Intervention Name(s)
isradipine
Other Intervention Name(s)
Dynacirc CR
Intervention Description
Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel
Primary Outcome Measure Information:
Title
MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures
Description
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.
Time Frame
baseline and week 4
Title
UPSA Communication Score
Description
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
Time Frame
baseline and week 4
Title
Quality of Life (QoL) Scale
Description
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.
Time Frame
baseline and Week 4
Secondary Outcome Measure Information:
Title
Mean Change in PRISE Adverse Event Checklist Score
Description
The PRISE is a physician-administered checklist of adverse events. PRISE contains 33 items, each defined by an adverse event. Each item is rated on a 3-point scale, ranging from 0 (not present) to 2 (distressing), with a total score range from 0-66, where higher scores indicate more adverse events. Mean change for adverse events at week 4 as compared to baseline
Time Frame
up to 4 weeks
Title
Number of Participants With Normal ECG
Description
Number of participants with normal ECG readings to confirm inclusion into study and compared at week 4 to baseline
Time Frame
baseline and week 4
Title
Number of Participants With Normal Chemistry Panel
Description
Number of participants with normal chemistry panel to confirm inclusion into study at baseline and week
Time Frame
baseline and week 4
Title
Number of Participants With Normal Complete Blood Count (CBC)
Description
Number of participants with normal CBC to confirm inclusion into study at baseline and week 4
Time Frame
baseline and week 4
Title
Abnormal Involuntary Movement Scale (AIMS)
Description
Mean change for abnormal involuntary movements throughout the study. The AIMS is a physician-administered scale of abnormal involuntary movements. AIMS consists of 10 items, each defined by a series of movements. Each item is rated on a 5-point scale, ranging from 0 (not observed) to 4 (severe), with a total score range from 0-40, where higher scores indicate abnormal involuntary movements.
Time Frame
baseline and Week 4
Title
Modified Simpson Angus Scale (MSAS)
Description
Mean change for drug-induced disordered movement throughout the study. The MSAS is a physician-administered scale of abnormal drug-induced movements. MSAS consists of 6 items, each defined by a series of movements. Each item is rated on a 5-point scale, ranging form 0 (not observed) to 4 (most severe), with a total range of 0-24, where higher scores indicate drug-induced disordered movement.
Time Frame
baseline and week 4
Title
Beck Scale for Suicidal Ideation (SSI)
Description
a 21-question multiple choice, self-report inventory that is used for measuring the severity of suicidal ideation. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe suicidal ideation symptoms.
Time Frame
up to 4 weeks
Title
Number of Participants With Suicidal Acknowledgments
Description
Number of participants with Suicidal acknowledgements based on the Columbia Suicide Severity Rating Scales (C-SSRS) - Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).
Time Frame
up to 4 weeks
Title
Number of Participants With a Confirmed SCID-IV
Description
Number of participants with confirm diagnosis for inclusion into study using the Structured Clinical Interview for the DSM-IV (SCID-IV)
Time Frame
baseline
Title
Brief Psychiatric Rating Scale (BPRS)
Description
Mean change for positive symptoms throughout the study. BPRS consists of 18 items, each defined by a series of symptoms. Each item is rated on a 7-point scale, ranging from 1 (not observed) to 7 (very severe), with a total score range from 18-126, where higher scores indicate psychiatric symptoms.
Time Frame
up to 4 weeks
Title
Scale for the Assessment of Negative Symptoms (SANS)
Description
Mean change of negative symptoms throughout the study. SANS consists of 22 items, each defined by a series of symptoms. Each item is rated on a 6-point scale, ranging from 0 (no presence) to 5 (severe presence), with a total range of 0-110, where higher scores indicate negative symptoms.
Time Frame
up to 4 weeks
Title
Hamilton Rating Scale for Depression (HRSD)
Description
Mean change of symptoms of depression throughout the study. HRSD consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where higher score indicates more depressive symptoms
Time Frame
up to 4 weeks
Title
Clinical Global Impression Scale (CGI)
Description
Mean change of clinical impression of severity of psychiatric illness throughout the study. CGI consists of one item, defined by severity of illness. It is rated on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with a total range score of 1-7, where higher score indicates severity of illness.
Time Frame
up to 4 weeks
Title
Clinician Administered Rating Scale for Mania (CARS-M)
Description
Mean change of symptoms of mania throughout the study. CARS-M contains 14 items rated from 0 (absent) to 5 (present) and one item scored 0 to 4, with total range from 0 to 74, where higher score indicates manic symptoms.
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Burdick, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

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