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| ID | Type | Description | Link |
|---|---|---|---|
| HSM# 12-00311 |
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| Name | Class |
|---|---|
| Brain & Behavior Research Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isradipine | Experimental | open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isradipine | Drug | Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Burdick, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Isradipine | Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. isradipine as utilized in this trial will be administered twice daily. Isradipine will be titrated as follows: baseline (week 0) 5 mg/day BID; Week 2 increase to 10 mg/day BID if 5 mg was well-tolerated. Dosing will be flexible based on side effects with a maximum=10 mg/day. If 5 mg cannot be tolerated, the subject will be discontinued. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Isradipine | Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. Isradipine as utilized in this trial will be administered twice daily. Isradipine will be titrated as follows: baseline (week 0) 5 mg/day BID; Week 2 increase to 10 mg/day BID if 5 mg was well-tolerated. Dosing will be flexible based on side effects with a maximum=10 mg/day. If 5 mg cannot be tolerated, the subject will be discontinued. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | z-score | baseline and week 4 |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isradipine | Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. isradipine as utilized in this trial will be administered twice daily. Isradipine will be titrated as follows: baseline (week 0) 5 mg/day BID; Week 2 increase to 10 mg/day BID if 5 mg was well-tolerated. Dosing will be flexible based on side effects with a maximum=10 mg/day. If 5 mg cannot be tolerated, the subject will be discontinued. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Burdick | Icahn School of Medicine at Mount Sinia | 212-659-8841 | katherine.burdick@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2017 | Nov 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017275 | Isradipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| up to 4 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Data not collected. | Posted | 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). | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 4 weeks |
|
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|
| 0 |
| 11 |
| 0 |
| 11 |
| 11 |
| 11 |
| Dizziness | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Poor coordination | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Blurred vision | Eye disorders | MedDRA (10.0) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
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| Frequent urination | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| Menstrual irregular | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Difficulty sleeping | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypersomnia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Loss of libido | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Poor concentration | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Restlessness | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Decreased energy | General disorders | MedDRA (10.0) | Systematic Assessment |
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