SchizophreniaNCT07006935
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
A study testing Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness and Usual Community-Based Mental Health Care in people with Schizophrenia and Schizo Affective Disorder, run by Case Western Reserve University at 1 site in United States.
Trial summary
The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders
- What is being tested?
- Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness and Usual Community-Based Mental Health Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) have a DSM-V diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform confirmed by diagnostic assessment and medical record review
- (2) between the ages of 18-50
- (3) stabilized on psychotropic medication as indicated by no changes to the primary psychiatric medication in the last month
- (4) able to read and speak fluent English at a sixth grade level or higher for purposes of informed consent and cognitive testing
- For Clubhouse members, they must be a first-time, newly enrolled member
Who cannot join
- (1) had previous membership at a Clubhouse (Magnolia or elsewhere)
- (2) have a current severe substance use disorder
- (3) have persistent suicidal or homicidal behavior
- (4) a co-occurring diagnosis of an intellectual or learning disability or neurodevelopment condition (e.g., Autism; based on chart review)
- (5) had recent psychiatric instability requiring hospitalization in the past month;
- (6) history of a traumatic brain injury (TBI; based on record review)
- (7) contraindicators for MRI (e.g., pacemaker, claustrophobia)
- Participants in the usual care will be excluded if they are a current Clubhouse member or join a Clubhouse during participation in this research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Jessica A Wojtalik, PhD, 216-368-1329, reach-study@case.edu
About this study
Official title: Pilot Study of the Cognitive and Neurobiological Effects of the Clubhouse Model of Psychosocial Rehabilitation for Schizophrenia and Related Conditions
The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.
- Being tested
- Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness, Usual Community-Based Mental Health Care
- Keywords
- Clubhouse Model of Psychosocial Rehabilitation, Community mental health interventions, Cognition, Brain functioning
- 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.
Clubhouse Model of Psychosocial Rehabilitation for Serious Mental IllnessBehavioural
The Clubhouse Model (CM) is a strengths-focused, evidence-based, and comprehensive approach to psychosocial rehabilitation for serious mental illness. The CM uses an intentional community of support to create a safe and holistic setting to practice real-world functioning. The core of the CM is the 'work-ordered day,' a concept where members, as opposed to patients, are integral to and needed for the successful daily operation of the Clubhouse. Members choose a 'work unit' each day of attendance. Most clubhouses have four work units, such as (1) Administration (e.g., database management); (2) Hospitality (e.g., Clubhouse cafe); (3) Membership (e.g., employment programs); and (4) Communications (e.g., newsletter). Other unique aspects include its voluntary and humanistic nature, prioritization of member choice, unrestricted and flexible membership, and the elimination of provider-patient hierarchy. The CM has a sophisticated accreditation process based on 37 international standards.
Usual Community-Based Mental Health CareBehavioural
Usual care includes services typically available in the community at mental health agencies, including case management, Assertive Community Treatment, counseling, peer support services, psychoeducational support groups, family support groups, supported education/employment, permanent supportive housing, and medication management.
| Study group | Role | What they receive |
|---|---|---|
| Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness | Experimental | The Clubhouse Model (CM) is a strengths-focused, evidence-based, and comprehensive approach to psychosocial rehabilitation for serious mental illness. The CM uses an intentional community of support to create a safe and holistic setting to practice real-world functioning. The core of the CM is the 'work-ordered day,' a concept where members, as opposed to patients, are integral to and needed for the successful daily operation of the Clubhouse. Members choose a 'work unit' each day of attendance. Most clubhouses have four work units, such as (1) Administration (e.g., database management); (2) Hospitality (e.g., Clubhouse cafe); (3) Membership (e.g., employment programs); and (4) Communications (e.g., newsletter). Other unique aspects include its voluntary and humanistic nature, prioritization of member choice, unrestricted and flexible membership, and the elimination of provider-patient hierarchy. The CM has a sophisticated accreditation process based on 37 international standards. Receives: Behavioral: Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness |
| Usual Community-Based Mental Health Care | Active comparator | Usual care includes services typically available in the community at mental health agencies, including case management, Assertive Community Treatment, counseling, peer support services, psychoeducational support groups, family support groups, supported education/employment, permanent supportive housing, and medication management. Receives: Behavioral: Usual Community-Based Mental Health Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB)
The MATRICS Consensus Cognitive Battery (MCCB), which was developed by NIMH as a standardized assessment tool as an outcome measure of cognitive change in intervention trials. This performance-based battery contains 10 field standard, individually administered computer and paper-and-pencil tests of neurocognition (processing speed, attention, working memory, verbal learning, visual learning, and problem solving) and social cognition. The MCCB takes approximately 60-90 minutes to administer. The overall composite score (M = 50, SD = 10) with higher scores indicated better cognitive performance.
Measured: Baseline and 6 months
Change in functional outcome as measured by Specific Levels of Functioning Scale (SLOF)
The SLOF is a 30-item self-and/or informant-report measure of interpersonal relationships, social acceptability, community activities, and living and work skills rated on a 5-point scale, with higher scores reflecting better functional outcome.
Measured: Baseline and 6 months
Change in quality of life as measured by World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)
The WHOQOL-BREF is a 26-item quality of life (QoL) measure developed by the World Health Organization of physical health, psychological, social relationships, and environment QoL. Items are rated on a 5-point scale, with higher scores reflecting better QoL.
Measured: Baseline and 6 months
Change in disability as measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0
A brief (12-item), universal interviewer/self-report measure of functional disability that assesses 6 areas (mobility, life activities, cognition, participation, self-care, getting along with others) rated on level of difficulty in the past 30 days with higher scores indicating more disability.
Measured: Baseline and 6 months
Change in task-based brain activation during functional MRI (fMRI) as measured by the AX-Continuous Performance Task (AX-CPT)
An NIMH validated fMRI task of goal maintenance (attention) in schizophrenia. This task implements the "A-then-X rule" where participants are instructed to make an index finger button press only when "A" precedes "X" (target trial, 72%) and a middle finger press for all other "non-target" trials (AY: 11%; BX: 11%; BY: 6%) for a total of 4 blocks of 36 trials (144 total). Trials are presented for 500ms followed by a cue (+) presentation for 1000ms (target or non-target response expected) with an interstimulus interval of 2000ms. Instructions and practice trials are embedded. The main contrast of interest for group-level analyses is the high vs. low cognitive load trials (cue A > cue B), with greater fronto-limbic brain activation during high cognitive load indicating strong attention-related brain activation.
Measured: Baseline and 6 months
Change in task-based brain activation during functional MRI (fMRI) as measured by the Emotional Faces N-Based Task (EFNBACK)
A modified version of the standard working memory n-back task. This task includes 8 blocks (4 are 0-back and 4 are 2-back) of 12 trials. Each block starts with instructions indicating the condition (0-back or 2-back) presented for 3500ms, which is followed by the target stimulus (letters) flanked by emotional valence distractor conditions (happy, fearful, neutral, or no face) for 500ms, with an interstimulus interval jittered at an average of 3500ms. Blocks with emotional vs. no distractors are randomly interspersed throughout. The main contrasts of interest for group-level analyses are working memory load (2-back > 0-back) and emotion distractor conditions (happy > neutral; fearful > neutral), with greater activation during the 2-back and emotional distractor conditions indicating better working memory and emotion regulation brain functioning.
Measured: Baseline and 6 months
Secondary outcomes (5)
Change in social cognition (emotion recognition) as measured by Penn Emotion Recognition Task (ER-40)
Measures the ability to accurately identify different emotions (i.e., happy, sad, anger, and fear) in 40 colored images of human faces with a computer-administered, performance-based, and forced-choice format. Generates a total score of correctly identified emotions, with higher scores indicative of better emotional recognition ability.
Measured: Baseline and 6 months
Change in social cognition (social inference) as measured by The Awareness of Social Inference Test, part III (TASIT)
The TASIT is a performance-based assessment that includes 16 short video vignettes (15 to 60 seconds) of social exchanges between actors. After watching a vignette, participants are asked four questions regarding their perceptions of lies or sarcasm in the social exchange. A total score is generated of correct responses, with higher scores indicative of better social inference ability.
Measured: Baseline and 6 months
Change in social cognition (theory of mind) as measured by the Hinting Task
Requires theory of mind to infer the genuine intentions of a character's indirect speech to a second character across 10 short stories read by the test administrator. Created as a performance-based measure of theory of mind ability in people with schizophrenia. A total score of correct responses is yielded, with higher scores reflecting stronger ability to correctly perceive the hint of the character's true intention.
Measured: Baseline and 6 months
Change in functional capacity as measured by he UCSD Performance-Based Skills Assessment, Brief version (UPSA-B)
The UCSD Performance-Based Skills Assessment is a brief performance-based measure of functional capacity of financial and communication skills. Scores range from 0 to 100, with higher scores indicating better functional capacity.
Measured: Baseline and 6 months
Change in Self-Efficacy as measured by the New General Self-Efficacy Scale (NGSE)
The New General Self-Efficacy Scale (NGSE) is an 8-item self-report questionnaire designed to assess an individual's overall belief in their ability to perform well across a variety of situations. Respondents rate their agreement with each statement on a 5-point Likert scale, ranging from 0 (strongly disagree) to 4 (strongly agree). The total score range is from 0-32 with higher scores indicating greater self-efficacy.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start30 Aug 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Magnolia Clubhouse, The Centers
- Responsible party
- Principal investigator, Jessica Wojtalik, Case Western Reserve University
- Investigators
- Jessica A Wojtalik, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006935
- Sponsor's protocol ID
- STUDY20250623
- Status last verified
- Apr 2026
- First submitted
- 28 May 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Cognitive and Neurobiological Effects of the Clubhouse Model of Psychosocial Rehabilitation for Schizophrenia and Related Conditions
- ClinicalTrials.gov ID
- NCT07006935
- Acronym / sponsor ID
- STUDY20250623
- Keywords
- Clubhouse Model of Psychosocial Rehabilitation, Community mental health interventions, Cognition, Brain functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Magnolia Clubhouse, The Centers
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 5 Jun 2025 (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.
The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness | Experimental | Behavioral: Clubhouse Model of Psychosocial Rehabilitation for Serious Mental IllnessThe Clubhouse Model (CM) is a strengths-focused, evidence-based, and comprehensive approach to psychosocial rehabilitation for serious mental illness. The CM uses an intentional community of support to create a safe and holistic setting to practice real-world functioning. The core of the CM is the 'work-ordered day,' a concept where members, as opposed to patients, are integral to and needed for the successful daily operation of the Clubhouse. Members choose a 'work unit' each day of attendance. Most clubhouses have four work units, such as (1) Administration (e.g., database management); (2) Hospitality (e.g., Clubhouse cafe); (3) Membership (e.g., employment programs); and (4) Communications (e.g., newsletter). Other unique aspects include its voluntary and humanistic nature, prioritization of member choice, unrestricted and flexible membership, and the elimination of provider-patient hierarchy. The CM has a sophisticated accreditation process based on 37 international standards. |
| Usual Community-Based Mental Health Care | Active comparator | Behavioral: Usual Community-Based Mental Health CareUsual care includes services typically available in the community at mental health agencies, including case management, Assertive Community Treatment, counseling, peer support services, psychoeducational support groups, family support groups, supported education/employment, permanent supportive housing, and medication management. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- (1) have a DSM-V diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform confirmed by diagnostic assessment and medical record review
- (2) between the ages of 18-50
- (3) stabilized on psychotropic medication as indicated by no changes to the primary psychiatric medication in the last month
- (4) able to read and speak fluent English at a sixth grade level or higher for purposes of informed consent and cognitive testing
- For Clubhouse members, they must be a first-time, newly enrolled member
Key exclusion criteria (8 listed)
- (1) had previous membership at a Clubhouse (Magnolia or elsewhere)
- (2) have a current severe substance use disorder
- (3) have persistent suicidal or homicidal behavior
- (4) a co-occurring diagnosis of an intellectual or learning disability or neurodevelopment condition (e.g., Autism; based on chart review)
- (5) had recent psychiatric instability requiring hospitalization in the past month;
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 |
|---|---|---|
| Clubhouse Model of Psychosocial Rehabilitation for Serious Mental IllnessThe Clubhouse Model (CM) is a strengths-focused, evidence-based, and comprehensive approach to psychosocial rehabilitation for serious mental illness. The CM uses an intentional community of support to create a safe and holistic setting to practice real-world functioning. The core of the CM is the 'work-ordered day,' a concept where members, as opposed to patients, are integral to and needed for the successful daily operation of the Clubhouse. Members choose a 'work unit' each day of attendance. Most clubhouses have four work units, such as (1) Administration (e.g., database management); (2) Hospitality (e.g., Clubhouse cafe); (3) Membership (e.g., employment programs); and (4) Communications (e.g., newsletter). Other unique aspects include its voluntary and humanistic nature, prioritization of member choice, unrestricted and flexible membership, and the elimination of provider-patient hierarchy. The CM has a sophisticated accreditation process based on 37 international standards. | Behavioural | Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness |
| Usual Community-Based Mental Health CareUsual care includes services typically available in the community at mental health agencies, including case management, Assertive Community Treatment, counseling, peer support services, psychoeducational support groups, family support groups, supported education/employment, permanent supportive housing, and medication management. | Behavioural | Usual Community-Based Mental Health Care |
Primary outcome
Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Baseline and 6 months
The MATRICS Consensus Cognitive Battery (MCCB), which was developed by NIMH as a standardized assessment tool as an outcome measure of cognitive change in intervention trials. This performance-based battery contains 10 field standard, individually administered computer and paper-and-pencil tests of neurocognition (processing speed, attention, working memory, verbal learning, visual learning, and problem solving) and social cognition. The MCCB takes approximately 60-90 minutes to administer. The overall composite score (M = 50, SD = 10) with higher scores indicated better cognitive performance.
Change in functional outcome as measured by Specific Levels of Functioning Scale (SLOF)
Time frame: Baseline and 6 months
The SLOF is a 30-item self-and/or informant-report measure of interpersonal relationships, social acceptability, community activities, and living and work skills rated on a 5-point scale, with higher scores reflecting better functional outcome.
Change in quality of life as measured by World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)
Time frame: Baseline and 6 months
The WHOQOL-BREF is a 26-item quality of life (QoL) measure developed by the World Health Organization of physical health, psychological, social relationships, and environment QoL. Items are rated on a 5-point scale, with higher scores reflecting better QoL.
Change in disability as measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0
Time frame: Baseline and 6 months
A brief (12-item), universal interviewer/self-report measure of functional disability that assesses 6 areas (mobility, life activities, cognition, participation, self-care, getting along with others) rated on level of difficulty in the past 30 days with higher scores indicating more disability.
Change in task-based brain activation during functional MRI (fMRI) as measured by the AX-Continuous Performance Task (AX-CPT)
Time frame: Baseline and 6 months
An NIMH validated fMRI task of goal maintenance (attention) in schizophrenia. This task implements the "A-then-X rule" where participants are instructed to make an index finger button press only when "A" precedes "X" (target trial, 72%) and a middle finger press for all other "non-target" trials (AY: 11%; BX: 11%; BY: 6%) for a total of 4 blocks of 36 trials (144 total). Trials are presented for 500ms followed by a cue (+) presentation for 1000ms (target or non-target response expected) with an interstimulus interval of 2000ms. Instructions and practice trials are embedded. The main contrast of interest for group-level analyses is the high vs. low cognitive load trials (cue A > cue B), with greater fronto-limbic brain activation during high cognitive load indicating strong attention-related brain activation.
Change in task-based brain activation during functional MRI (fMRI) as measured by the Emotional Faces N-Based Task (EFNBACK)
Time frame: Baseline and 6 months
A modified version of the standard working memory n-back task. This task includes 8 blocks (4 are 0-back and 4 are 2-back) of 12 trials. Each block starts with instructions indicating the condition (0-back or 2-back) presented for 3500ms, which is followed by the target stimulus (letters) flanked by emotional valence distractor conditions (happy, fearful, neutral, or no face) for 500ms, with an interstimulus interval jittered at an average of 3500ms. Blocks with emotional vs. no distractors are randomly interspersed throughout. The main contrasts of interest for group-level analyses are working memory load (2-back > 0-back) and emotion distractor conditions (happy > neutral; fearful > neutral), with greater activation during the 2-back and emotional distractor conditions indicating better working memory and emotion regulation brain functioning.
5 secondary outcomes
Change in social cognition (emotion recognition) as measured by Penn Emotion Recognition Task (ER-40)
Time frame: Baseline and 6 months
Change in social cognition (social inference) as measured by The Awareness of Social Inference Test, part III (TASIT)
Time frame: Baseline and 6 months
Change in social cognition (theory of mind) as measured by the Hinting Task
Time frame: Baseline and 6 months
Change in functional capacity as measured by he UCSD Performance-Based Skills Assessment, Brief version (UPSA-B)
Time frame: Baseline and 6 months
Change in Self-Efficacy as measured by the New General Self-Efficacy Scale (NGSE)
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- 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.
Jessica A Wojtalik, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness and Usual Community-Based Mental Health Care in people with Schizophrenia and Schizo Affective Disorder, run by Case Western Reserve University 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica A Wojtalik, PhD (216-368-1329, reach-study@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB) (time frame: Baseline and 6 months). The study lists 6 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 17 Aug 2026.