Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

Schizophrenia Clinical Trial

Official title:

A Molecular Approach to Treat Cognition in Schizophrenia: Ca2+ Channel Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658150
• Other study ID #: GCO 12-0679
• Secondary ID: HSM# 12-00311
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: January 2, 2018

Study information

• Verified date: November 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	up to 4 weeks
Secondary	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	baseline and week 4
Secondary	Number of Participants With Normal Chemistry Panel	Number of participants with normal chemistry panel to confirm inclusion into study at baseline and week	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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.	baseline and Week 4
Secondary	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.	baseline and week 4
Secondary	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.	up to 4 weeks
Secondary	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).	up to 4 weeks
Secondary	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)	baseline
Secondary	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.	up to 4 weeks
Secondary	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.	up to 4 weeks
Secondary	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	up to 4 weeks
Secondary	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.	up to 4 weeks
Secondary	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.	up to 4 weeks