SchizophreniaNCT01658150
Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder
A study testing isradipine in people with Schizophrenia and Schizoaffective Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- isradipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 2 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Molecular Approach to Treat Cognition in Schizophrenia: Ca2+ Channel Blockade
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- isradipine
- Keywords
- Cognition, Schizophrenia, Schizoaffective disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isradipineDrug
Also called Dynacirc CR
Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel
| Study group | Role | What they receive |
|---|---|---|
| isradipine | Experimental | open label Receives: Drug: isradipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: baseline and Week 4
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startSep 2012
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Katherine Burdick, Icahn School of Medicine at Mount Sinai
- Investigators
- Katherine Burdick, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658150
- Sponsor's protocol ID
- GCO 12-0679
- Other IDs
- HSM# 12-00311
- Status last verified
- Nov 2018
- First submitted
- 12 Jul 2012
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecular Approach to Treat Cognition in Schizophrenia: Ca2+ Channel Blockade
- ClinicalTrials.gov ID
- NCT01658150
- Acronym / sponsor ID
- GCO 12-0679
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Cognition, Schizophrenia, Schizoaffective disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- Sep 2012
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Posted 5 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isradipine | Experimental | Drug: isradipineopen label |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isradipineAlso: Dynacirc CRIsradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel | Drug | isradipine |
Primary outcome
MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures
Time frame: 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
Time frame: 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
Time frame: 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.
14 secondary outcomes
Mean Change in PRISE Adverse Event Checklist Score
Time frame: up to 4 weeks
Number of Participants With Normal ECG
Time frame: baseline and week 4
Number of Participants With Normal Chemistry Panel
Time frame: baseline and week 4
Number of Participants With Normal Complete Blood Count (CBC)
Time frame: baseline and week 4
Abnormal Involuntary Movement Scale (AIMS)
Time frame: baseline and Week 4
Modified Simpson Angus Scale (MSAS)
Time frame: baseline and week 4
Beck Scale for Suicidal Ideation (SSI)
Time frame: up to 4 weeks
Number of Participants With Suicidal Acknowledgments
Time frame: up to 4 weeks
Number of Participants With a Confirmed SCID-IV
Time frame: baseline
Brief Psychiatric Rating Scale (BPRS)
Time frame: up to 4 weeks
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: up to 4 weeks
Hamilton Rating Scale for Depression (HRSD)
Time frame: up to 4 weeks
Clinical Global Impression Scale (CGI)
Time frame: up to 4 weeks
Clinician Administered Rating Scale for Mania (CARS-M)
Time frame: up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Burdick, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isradipine in people with Schizophrenia and Schizoaffective Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures (time frame: baseline and week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.