Bipolar I DisorderPhase 3CARPZ-01NCT04771299
Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients
A Phase 3 study testing Cariprazine in people with Bipolar I Disorder and Cognitive Impairment, run by Lakshmi N Yatham at 1 site in Canada.
Trial summary
Some patients with bipolar disorder show broad cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.) that persist during euthymia (no symptoms of depression or mania) despite remission of mood symptoms. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Bipolar I Disorder, Cognitive Impairment
- What is being tested?
- Cariprazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jul 2021to 8 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Participant Inclusion Criteria Participants who meet all of the following criteria are eligible to participate in this trial.
- Males or females aged 19 to 65 years inclusive.
- DSM-5 diagnosis of Bipolar I Disorder, with or without a history of psychosis.
- All patients must be taking either a mood stabilizer (i.e. lithium or valproate) or an atypical antipsychotic, or a combination of these (two mood stabilizers or a mood stabilizer plus an atypical antipsychotic), at therapeutic doses, for mood stabilization. Those taking two or more atypical antipsychotics are excluded. Medications and therapeutic doses are: lithium, serum level 0.6-1.2 mEq/L; divalproex/sodium valproate, serum level 350-700 mM/L (45-125 mcg/ml); risperidone 1-6 mg/day; olanzapine 5-20 mg/day; quetiapine IR or XR 300-800 mg/day; aripiprazole 10-30 mg/day; asenapine 5-20 mg/day, or ziprasidone 80-160 mg/day.
- All concomitant medication must be at a stable dose for a minimum of two weeks prior to randomization.
- Clinically stable during the last 4 weeks, as assessed by clinical interview, prior to the randomization visit.
- A MADRS and YMRS score less than or equal to 8.
- Patients who show cognitive impairments, defined as 0.5 standard deviations below the mean or worse (Z = -0.5 or lower), on either the WAIS-IV Coding subtest, or the RAVLT total learning score on trials 1-5 or immediate recall trial, at screening visit.
- A WAIS-IV vocabulary scaled score ≥ 5 (equivalent to estimated IQ 80 or greater).
- A sufficient level of English language.
- Females who are postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) or are surgically sterile.
- Females of childbearing potential who are taking contraceptive pills or agree to practice highly effective double barrier methods of contraception, from the time of signing the informed consent up to the last dose of study drug, and for 7 days after the last dose. Abstinence will only be considered an adequate form of contraception if it is the usual and preferred method.
- Capability of understanding, consenting to, and complying with study requirements, study visits, and to return to the clinic for follow-up evaluations as specified by the protocol.
4.2 Participant Exclusion Criteria Participants meeting any of the following criteria are not eligible to participate in the trial.
- A history of unstable or inadequately treated medical illnesses including moderate to severe brain injury, or neurological illnesses impacting cognitive function. Patients with a personal or family history of cardiac problems will need to undergo EKG at screen visit, and will be excluded if results are abnormal.
- Participants taking procognitive medications, clozapine, tricyclic antidepressants, first-generation antipsychotics, benztropine, cogentin or lurasidone at screening visit.
- Those taking two or more antipsychotics.
- Anticholinergics and stimulants that increase dopamine levels are not permitted.
- Cognitive remediation therapy within 3 months prior to entry or during the double blind phase.
- Neuromodulation treatment with ECT or DBS within 8 weeks, or rTMS, tDCS or experimental drug treatment within 30days.
- History of nonresponse or intolerance to cariprazine.
- Psychiatric disorder other than bipolar disorder.
- Participants who currently meet criteria for anxiety disorder (GAD, OCD, panic disorder, PTSD).
- Those with a current or lifetime diagnosis of ADHD or other learning disorders.
- Those meeting DSM-5 criteria for alcohol or substance abuse or dependence disorder within the past month.
- Significant risk of harm to self or others.
- Those with severe personality disorders causing significant impairment in functioning.
- Pregnancy or lactation.
- Liver function tests (AST and ALT) three times the upper limit of normal.
- Contraindications to cariprazine according to prescribing information.
- Participants with increased risk or diagnosis of impulsive or compulsive behavior
Trial locations and contacts
1 site in 1 country.
Canada1 site
Djavad Mowfaghian Centre for Brain Heath
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Efficacy of Cariprazine in Improving Cognitive Functioning in Euthymic Patients With Bipolar I Disorder: A Proof of Concept Randomized, Double Blind Placebo Controlled Trial
Some patients with bipolar disorder show broad cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.) that persist during euthymia (no symptoms of depression or mania) despite remission of mood symptoms. Cognitive deficits (significant cognitive impairments) in bipolar disorder are associated with impairments in everyday functioning and quality of life. Thus, improving cognitive functioning is an important treatment goal in people with bipolar disorder. In a recent study, investigators have demonstrated that lurasidone; an atypical antipsychotic was more effective than treatment as usual in improving cognition. The study will examine the efficacy of Cariprazine (VRAYLAR®) in improving cognition in patients with bipolar disorder. Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder. This study is a randomized (like the flip of a coin), double-blind (participant and the study team will not know which treatment arm participant will receive) study in which 30 participants will be randomized across two sites in Canada.
Read the detailed description
Specific Procedures: If participant agrees to take part in this study, the procedures and visits include the following:
Screening Visit: (approximately 3.0 hours):Prior to any procedures being conducted, the Informed Consent Form will be reviewed with participant in detail and participant will have the opportunity to decide if s/he wish to participate in the study or not. If participant meets all the requirements and all of participants questions have been answered, participant will be asked to sign the consent form. A clinical assessment will take place, where participant will be asked questions about participants medical and psychiatric history including family psychiatric history and prior treatments. Participants medical records may be reviewed to confirm diagnosis and treatment history. The study doctor will complete rating scales to determine the current status of participants mood. Participant may choose not to answer any questions that participant is uncomfortable with. Neurocognitive tests (i.e., paper and pencil tests of memory, problem solving etc. as well as a computer component) will be conducted to determine if cognitive impairment exists. If there is no cognitive impairment no further procedures will be conducted. The information that is collected from the participant will not be used for any purpose other than stating how many people were screened for study participation. If cognitive impairment does exist, participant will be scheduled to return to the clinic within 4 weeks and a baseline visit will be completed. In addition to the above procedures, participant will also have a physical examination, which includes measurement of participants height, weight and blood pressure. To ensure safety of participation in the study, participant will be asked to have routine clinical blood work, including a pregnancy test for female participants of childbearing age, and a urine test for a drug screen. If participant has a personal or family history of significant cardiac problems or show cardiac abnormalities on the physical exam an EKG will be performed.
Baseline Visit (approximately 3-3.5 hours): At baseline, rating scales and clinical assessment will be completed to determine the current status of participants mood. Information about participants current medications and any side effects will be obtained. If participant is not eligible, participants will not be randomized into the study and no further procedures will be conducted.
If participant is eligible, participant will be randomized to receive either cariprazine or placebo in addition to participants current medications, and instructed on dosing. Participant will complete more neurocognitive testings. The use of benzodiazepines (Ativan, Lorazepam etc.) within 4 hours or caffeine intake 2 hours prior to neurocognitive testing is not allowed. Participant will be asked to complete questionnaires about participants functioning and quality of life. Vital signs and weight measurements will be obtained. Study medication will be dispensed to last until the next clinic visit. Participant must bring the remaining unused medication to the next appointment. Participant is asked to give 1.5 tablespoons (20 ml) of blood to analyze markers which may be predictive of bipolar disorder (biomarkers). Biomarkers are substances (like proteins, protein particles, or chemicals that make body function) that may be altered in those with bipolar disorder or may provide information about treatment response. These samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at the study site until they are sent for analysis at the end of the study.
Weeks 1, 2 and 4: (approximately 15 minutes each): Participant will be contacted by telephone to review any changes to participants medications and any side effects that may be experienced.
Week 3 Clinic appointment: (approximately 1 hour) : A clinical assessment will take place, where participant is asked questions about their mood. Information about participants current medications and any side effects will be obtained. Vital signs and weight measurements will be obtained. Bottle-1 of the study medication will be collected and bottle-2 of study medication will be dispensed. Participant will be asked to bring the remaining unused study medication from bottle-2 to the next clinic appointment. Participant will be asked to give a tablespoon (15 ml) of blood to test for levels of study medication. The samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at study site until they are sent for analysis at the end of the study.
Week 6/ Early Termination Visit: (approximately 3 hours): A clinical assessment will take place where participant will be asked questions about their mood. Neurocognitive testing will be administered to all participants who have had a minimum of 3 weeks of double- blind treatment. Participant is asked to complete some questionnaires about participants functioning and quality of life. Information about participants current medications and any side effects will be obtained. Vital signs and weight measurements will be obtained. Participant will have a physical examination and will be asked to complete routine laboratory tests including a pregnancy test for female participants of childbearing age, and a urine drug screen. In addition, participant is asked to give 2 tablespoons (30 ml) of blood to measure levels of study medication, and biomarkers. These samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at study site until they are sent for analysis at the end of the study.
Follow-up Telephone Assessment (2 weeks after study completion; approximately 15 minutes): Participant will be contacted by telephone to assess any side effects or issues post treatment.
- Conditions
- Bipolar I Disorder, Cognitive Impairment
- Being tested
- Cariprazine, Placebo
- Keywords
- Bipolar I Disorder, Euthymia, Cariprazine, Cognition, Memory
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CariprazineDrug
Also called VRAYLAR®
Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder.
PlaceboOther
Placebo is an inactive substance that looks identical to the study medication that contains no therapeutic ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine | Active comparator | 1.5mg of Cariprazine added to their current treatment for 6 week period Receives: Drug: Cariprazine |
| Placebo | Placebo comparator | Matching placebo added to their current treatment for 6 week period. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cognitive performance
The primary efficacy measure will be improvement in cognitive performance, as measured by changes in composite cognitive score from baseline to endpoint, extracted from the International Society for Bipolar Disorders-Battery for Assessment of Neurocognition. The higher the scores the better the outcome.
Measured: 6 weeks
Improvement in functioning
The co-primary efficacy measure will include changes in functioning from baseline to endpoint measured using UCSD based performance skills assessment-brief version. The higher the scores the better the outcome.
Measured: 6 weeks
Secondary outcomes (7)
Change in depression
Montgomery Asberg Depression Rating Scale will be used to assess changes in bipolar depression from baseline to endpoint. Lower scores reflect better clinical outcomes.
Measured: 6 weeks
Change in Mania
The Young Mania Rating Scale will be used to assess changes in mania from baseline to endpoint. The higher the scores means worsening in Mania. Lower scores reflect better clinical outcomes.
Measured: 6 weeks
Improvement in overall psychiatric status
Clinical Global Improvement Scale will be used to assess change from baseline to endpoint in overall psychiatric status. The higher the scores means worsening in psychiatric status .
Measured: 6 weeks
Improvement in Quality of Life
Quality of Life, Bipolar Version Scale will be used to assess improvement in quality of life from baseline to endpoint. Higher scores reflect better outcomes.
Measured: 6 weeks
Improvement in Subjective-rated Cognitive Functioning
Cognitive Complaints in Bipolar Disorder Rating Assessment will be used to assess changes in subjective cognitive functioning from baseline to endpoint. Lower scores mean better outcomes.
Measured: 6 weeks
Improvement in Objectively Rated Daily Functioning
Functioning Assessment Short Test will be used to assess improvement in objectively rated daily functioning, defined as change in scores from baseline to endpoint. Higher scores mean better outcomes.
Measured: 6 weeks
Improvement in Subjectively Rated Daily Functioning
Sheehan Disability Scale (SDS) will be used to assess improvement in subjectively rated daily functioning, defined as change in scores from baseline to endpoint. Lower scores mean better outcomes.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start7 Jul 2021
- Primary completion8 Sep 2024
- Study completion8 Sep 2024
Why it stopped: Research support no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakshmi N Yatham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lakshmi N Yatham, University of British Columbia
- Investigators
- Lakshmi N Yatham, MBBS,MRCPsyc, Principal investigator, University of British Columbia, Department of Psychiatry, BC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771299
- Sponsor's protocol ID
- H20-01293
- Acronym
- CARPZ-01
- Status last verified
- Oct 2024
- First submitted
- 22 Feb 2021
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cariprazine in Improving Cognitive Functioning in Euthymic Patients With Bipolar I Disorder: A Proof of Concept Randomized, Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04771299
- Acronym / sponsor ID
- CARPZ-01 / H20-01293
- Conditions
- Bipolar I Disorder, Cognitive Impairment
- Keywords
- Bipolar I Disorder, Euthymia, Cariprazine, Cognition, Memory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research support no longer available.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Lakshmi N YathamUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 8 Sep 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some patients with bipolar disorder show broad cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.) that persist during euthymia (no symptoms of depression or mania) despite remission of mood symptoms. Cognitive deficits (significant cognitive impairments) in bipolar disorder are associated with impairments in everyday functioning and quality of life. Thus, improving cognitive functioning is an important treatment goal in people with bipolar disorder. In a recent study, investigators have demonstrated that lurasidone; an atypical antipsychotic was more effective than treatment as usual in improving cognition. The study will examine the efficacy of Cariprazine (VRAYLAR®) in improving cognition in patients with bipolar disorder. Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder. This study is a randomized (like the flip of a coin), double-blind (participant and the study team will not know which treatment arm participant will receive) study in which 30 participants will be randomized across two sites in Canada.
Detailed description
Specific Procedures: If participant agrees to take part in this study, the procedures and visits include the following:
Screening Visit: (approximately 3.0 hours):Prior to any procedures being conducted, the Informed Consent Form will be reviewed with participant in detail and participant will have the opportunity to decide if s/he wish to participate in the study or not. If participant meets all the requirements and all of participants questions have been answered, participant will be asked to sign the consent form. A clinical assessment will take place, where participant will be asked questions about participants medical and psychiatric history including family psychiatric history and prior treatments. Participants medical records may be reviewed to confirm diagnosis and treatment history. The study doctor will complete rating scales to determine the current status of participants mood. Participant may choose not to answer any questions that participant is uncomfortable with. Neurocognitive tests (i.e., paper and pencil tests of memory, problem solving etc. as well as a computer component) will be conducted to determine if cognitive impairment exists. If there is no cognitive impairment no further procedures will be conducted. The information that is collected from the participant will not be used for any purpose other than stating how many people were screened for study participation. If cognitive impairment does exist, participant will be scheduled to return to the clinic within 4 weeks and a baseline visit will be completed. In addition to the above procedures, participant will also have a physical examination, which includes measurement of participants height, weight and blood pressure. To ensure safety of participation in the study, participant will be asked to have routine clinical blood work, including a pregnancy test for female participants of childbearing age, and a urine test for a drug screen. If participant has a personal or family history of significant cardiac problems or show cardiac abnormalities on the physical exam an EKG will be performed.
Baseline Visit (approximately 3-3.5 hours): At baseline, rating scales and clinical assessment will be completed to determine the current status of participants mood. Information about participants current medications and any side effects will be obtained. If participant is not eligible, participants will not be randomized into the study and no further procedures will be conducted.
If participant is eligible, participant will be randomized to receive either cariprazine or placebo in addition to participants current medications, and instructed on dosing. Participant will complete more neurocognitive testings. The use of benzodiazepines (Ativan, Lorazepam etc.) within 4 hours or caffeine intake 2 hours prior to neurocognitive testing is not allowed. Participant will be asked to complete questionnaires about participants functioning and quality of life. Vital signs and weight measurements will be obtained. Study medication will be dispensed to last until the next clinic visit. Participant must bring the remaining unused medication to the next appointment. Participant is asked to give 1.5 tablespoons (20 ml) of blood to analyze markers which may be predictive of bipolar disorder (biomarkers). Biomarkers are substances (like proteins, protein particles, or chemicals that make body function) that may be altered in those with bipolar disorder or may provide information about treatment response. These samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at the study site until they are sent for analysis at the end of the study.
Weeks 1, 2 and 4: (approximately 15 minutes each): Participant will be contacted by telephone to review any changes to participants medications and any side effects that may be experienced.
Week 3 Clinic appointment: (approximately 1 hour) : A clinical assessment will take place, where participant is asked questions about their mood. Information about participants current medications and any side effects will be obtained. Vital signs and weight measurements will be obtained. Bottle-1 of the study medication will be collected and bottle-2 of study medication will be dispensed. Participant will be asked to bring the remaining unused study medication from bottle-2 to the next clinic appointment. Participant will be asked to give a tablespoon (15 ml) of blood to test for levels of study medication. The samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at study site until they are sent for analysis at the end of the study.
Week 6/ Early Termination Visit: (approximately 3 hours): A clinical assessment will take place where participant will be asked questions about their mood. Neurocognitive testing will be administered to all participants who have had a minimum of 3 weeks of double- blind treatment. Participant is asked to complete some questionnaires about participants functioning and quality of life. Information about participants current medications and any side effects will be obtained. Vital signs and weight measurements will be obtained. Participant will have a physical examination and will be asked to complete routine laboratory tests including a pregnancy test for female participants of childbearing age, and a urine drug screen. In addition, participant is asked to give 2 tablespoons (30 ml) of blood to measure levels of study medication, and biomarkers. These samples will be labelled with a unique study number and will not contain any identifying information. The samples will be stored at study site until they are sent for analysis at the end of the study.
Follow-up Telephone Assessment (2 weeks after study completion; approximately 15 minutes): Participant will be contacted by telephone to assess any side effects or issues post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cariprazine | Active comparator | Drug: Cariprazine1.5mg of Cariprazine added to their current treatment for 6 week period |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo added to their current treatment for 6 week period. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CariprazineAlso: VRAYLAR®Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder. | Drug | Cariprazine |
| PlaceboPlacebo is an inactive substance that looks identical to the study medication that contains no therapeutic ingredient. | Other | Placebo |
Primary outcome
Improvement in cognitive performance
Time frame: 6 weeks
The primary efficacy measure will be improvement in cognitive performance, as measured by changes in composite cognitive score from baseline to endpoint, extracted from the International Society for Bipolar Disorders-Battery for Assessment of Neurocognition. The higher the scores the better the outcome.
Improvement in functioning
Time frame: 6 weeks
The co-primary efficacy measure will include changes in functioning from baseline to endpoint measured using UCSD based performance skills assessment-brief version. The higher the scores the better the outcome.
7 secondary outcomes
Change in depression
Time frame: 6 weeks
Change in Mania
Time frame: 6 weeks
Improvement in overall psychiatric status
Time frame: 6 weeks
Improvement in Quality of Life
Time frame: 6 weeks
Improvement in Subjective-rated Cognitive Functioning
Time frame: 6 weeks
Improvement in Objectively Rated Daily Functioning
Time frame: 6 weeks
Improvement in Subjectively Rated Daily Functioning
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Research support no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Lakshmi N Yatham, MBBS,MRCPsyc principal investigator
University of British Columbia, Department of Psychiatry, BC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cariprazine in people with Bipolar I Disorder and Cognitive Impairment, run by Lakshmi N Yatham at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 26 Oct 2024. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Research support no longer available.). Results are not available in the source record.
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?
Improvement in cognitive performance (time frame: 6 weeks). The study lists 2 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 26 Oct 2024.