Clinical trial NCT01658150: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Cognition
Schizophrenia
Schizoaffective disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2012-08-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures
timeFrame: baseline and week 4
measure: UPSA Communication Score
timeFrame: baseline and week 4
measure: Quality of Life (QoL) Scale
timeFrame: baseline and Week 4
Secondary outcomes:
measure: Mean Change in PRISE Adverse Event Checklist Score
timeFrame: up to 4 weeks
measure: Number of Participants With Normal ECG
timeFrame: baseline and week 4
measure: Number of Participants With Normal Chemistry Panel
timeFrame: baseline and week 4
measure: Number of Participants With Normal Complete Blood Count (CBC)
timeFrame: baseline and week 4
measure: Abnormal Involuntary Movement Scale (AIMS)
timeFrame: baseline and Week 4
measure: Modified Simpson Angus Scale (MSAS)
timeFrame: baseline and week 4
measure: Beck Scale for Suicidal Ideation (SSI)
timeFrame: up to 4 weeks
measure: Number of Participants With Suicidal Acknowledgments
timeFrame: up to 4 weeks
measure: Number of Participants With a Confirmed SCID-IV
timeFrame: baseline
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: up to 4 weeks
measure: Scale for the Assessment of Negative Symptoms (SANS)
timeFrame: up to 4 weeks
measure: Hamilton Rating Scale for Depression (HRSD)
timeFrame: up to 4 weeks
measure: Clinical Global Impression Scale (CGI)
timeFrame: up to 4 weeks
measure: Clinician Administered Rating Scale for Mania (CARS-M)
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Katherine Burdick, PhD
role: PRINCIPAL_INVESTIGATOR
References: