Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

Not Applicable

Completed

Conditions: Schizophrenia
Schizoaffective Disorder

Interventions: Drug: isradipine

Registration Number: NCT01658150

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
isradipine	isradipine	open label

Primary Outcome Measures

Name	Time	Method
MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures	baseline and week 4	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	baseline and week 4	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	baseline and Week 4	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

Name	Time	Method
Number of Participants With Normal Complete Blood Count (CBC)	baseline and week 4	Number of participants with normal CBC to confirm inclusion into study at baseline and week 4
Mean Change in PRISE Adverse Event Checklist Score	up to 4 weeks	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	baseline and week 4	Number of participants with normal ECG readings to confirm inclusion into study and compared at week 4 to baseline
Clinician Administered Rating Scale for Mania (CARS-M)	up to 4 weeks	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.
Number of Participants With Normal Chemistry Panel	baseline and week 4	Number of participants with normal chemistry panel to confirm inclusion into study at baseline and week
Hamilton Rating Scale for Depression (HRSD)	up to 4 weeks	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
Abnormal Involuntary Movement Scale (AIMS)	baseline and Week 4	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.
Beck Scale for Suicidal Ideation (SSI)	up to 4 weeks	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	up to 4 weeks	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	baseline	Number of participants with confirm diagnosis for inclusion into study using the Structured Clinical Interview for the DSM-IV (SCID-IV)
Clinical Global Impression Scale (CGI)	up to 4 weeks	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.
Modified Simpson Angus Scale (MSAS)	baseline and week 4	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.
Brief Psychiatric Rating Scale (BPRS)	up to 4 weeks	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)	up to 4 weeks	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.