Schizophrenia Clinical Trial
Official title:
A Molecular Approach to Treat Cognition in Schizophrenia: Ca2+ Channel Blockade
Verified date | November 2018 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Brain & Behavior Research Foundation |
United States,
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 |
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