A Phase 4 interventional study of Risperidone in Schizophrenia Spectrum and Other Psychotic Disorders, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Basic science
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Among 32 studies in Schizophrenia Spectrum and Other Psychotic Disorders with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Schizophrenia Spectrum and Other Psychotic Disorders · United States.
Among the 32 studies in Schizophrenia Spectrum and Other Psychotic Disorders with a site in United States, this one is the 19th largest by enrollment of the 26 interventional ones that give a count, is one of 3 that started in 2017, is one of 2 in phase 4, and was the 16th registered.
84 studies on the registry are indexed under Schizophrenia Spectrum and Other Psychotic Disorders; 14 are open to participants now.
Browse Schizophrenia Spectrum and Other Psychotic Disorders studies →3 of the 32 studies in Schizophrenia Spectrum and Other Psychotic Disorders with a site in United States are open now. Recruiting first, the newest first:
MapLight Therapeutics · Sites in United States, Argentina, Bulgaria and 12 more countries
Ages 55–90
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18–40
MapLight Therapeutics · Sites in United States, Bulgaria, France
Ages 55–91
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Schizophrenia Spectrum and Other Psychotic Disorders studies recruiting now, 7 (64%) set no upper age limit and 3 (27%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years to 35 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 26 is below the median of 90 across 67 interventional studies indexed under Schizophrenia Spectrum and Other Psychotic Disorders.
Median enrollment 56 across the 26 interventional studies, 266 across the 6 observational. Of the 25 that completed or were terminated, 11 (44%) have results posted.
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9 of 32 have an industry lead sponsor. The 10 most frequent:
Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Weill Medical College of Cornell University has 1 study filed under Schizophrenia Spectrum and Other Psychotic Disorders — fewer than ten, so there is no comparison to draw.
2 of the studies in Schizophrenia Spectrum and Other Psychotic Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05877716University of MinnesotaEPI-MINN: Targeting Cognition and Motivation - National | 2027-03-31 |
| NCT06740383Beth Israel Deaconess Medical CenterBiomarkers/Biotypes, Course of Early Psychosis and Specialty Services | 2027-06-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 32 studies in Schizophrenia Spectrum and Other Psychotic Disorders with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Schizophrenia (SZ) is a highly debilitating neuropsychiatric disorder of young adulthood onset and a leading cause of disability worldwide. While treatments delivered at early stages of the disorder may be effective at reducing psychosis or altering the course of the disease, there are currently no biomarkers capable of identifying subjects in early stages of SZ who are likely to respond to treatment and would be good candidates for available proactive, symptomatic or future disease-modifying treatments; or those who would not respond and can be spared unnecessary medication exposure. The lack of these vitally important biomarkers provides a compelling rationale for the present multidisciplinary research project, which aims to develop and validate highly promising noninvasive and objective proton magnetic resonance spectroscopy (1H MRS)-based biomarkers for monitoring treatment response in early stages of SZ. In support of the viability of this overall objective is a large body of data, reported by the applicants and others, that show (a) that levels of glutamate (Glu) and - aminobutyric acid (GABA) - respectively, the major excitatory and inhibitory amino acid neurotransmitter systems - are abnormally elevated in medication-naïve and unmedicated first episode and chronic SZ patients; (b) that the effect of treatment with antipsychotic medications in these populations may be to lower or normalize brain levels of both Glu and GABA. To investigate the potential of these in vivo brain Glu and GABA abnormalities to serve as biomarkers of treatment response in early-stage SZ, the applicants propose to use 1H MRS to measure Glu and GABA levels in the largest cohort of medication-free SZ subjects to date, at baseline and following 4 weeks of antipsychotic treatment.
Inclusion Criteria (Patients):
Exclusion Criteria (Patients):
Inclusion Criteria (Healthy Controls)
Exclusion Criteria (Healthy Controls)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medication-free individuals during first-episode of psychosis who will receive 4 weeks of treatment with risperidone
Drug: Risperidone
Healthy, psychosis-free controls who will not receive risperidone
Participants will meet with a study doctor physician once per week (about 3 times total) to monitor progress and side-effects of risperidone, which includes taking 4 assessments each time. After 4 weeks of taking Risperidone, participant will be assessed and scanned with the MRI/MRS scanner again.
Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Gamma Amino Butyric Acid (GABA) Levels
Dorsal Caudate (DCA) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of GABA levels, over water, in the dorsal caudate. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
Time frame: Baseline and 4 weeks of treatment for patients, baseline for controls
Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Glx (Glutamate+Glutamine)
Dorsal Caudate (DCA) Glx levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of the levels of Glx over water in the dorsal caudate. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
Time frame: Baseline and 4th week of treatment for patients, baseline only for controls
Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Gamma Amino Butyric Acid (GABA)
Medial Prefrontal Cortex (MPFC) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of GABA levels, over water, in the mPFC. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
Time frame: Baseline and 4th week of treatment for patients, baseline only for controls
Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Glx (Glutamate+Glutamine)
Medial Prefrontal Cortex (MPFC) Glx levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of glx levels, over water, in the mPFC. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
Time frame: Baseline and 4th week of treatment for patients, baseline for controls
Changes in Neurocognitive Performance: MATRICS Consensus Cognitive Battery (MCCB)
Memory, attention, reasoning, emotional intelligence, and verbal ability will be assessed using the MCCB before and after 4 weeks of treatment. 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 percentile score. This score can go from 0 to 100 where a higher score indicates a better performance. For patients this is a change measure. For control subjects, this is a one time measure.
Time frame: Baseline and 4th week of of treatment for patients, baseline only for controls
WAMI (Wealth Asset and Income)
The WAMI Score at Baseline is a measure of socioeconomic status across countries and culture. The index scale goes from 0 (lower socioeconomic situation) to 1 (highest socioeconomic situation).
Time frame: Baseline
Changes in Clinical Symptomatology: Positive and Negative Syndrome Scale (PANSS)
Changes in Positive and Negative Symptoms will be assessed across the treatment period using the PANSS. Participants are rated on a scale of 1. (Absent) 2. (Minimal) 3. (Mild) 4. (Moderate) 5. (Moderate severe) 6. (Severe) 7. (Extreme) to describe Positive, Negative and General symptomatology. Items from each subscale (Positive, Negative, and General) are summed for their respective scales, with lower numbers indicating less severe or absent symptomatology, and higher scores indicating more severe symptoms. A total sum of all subscales is also computed to reflect overall symptom severity. Positive Subscale: 7 items, minimum score = 7, maximum score = 49 Negative Subscale: 7 items, minimum score = 7, maximum score = 49 General Subscale: '16 items, minimum score = 16, maximum score = 112 Total Score: 30 items, minimum score = 30, maximum score = 210. For patients this is a change measure. For control subjects, this is a one time measure.
Time frame: Baseline and week 4 for patients; for controls only baseline
Changes in Motor Symptomatology: Abnormal Involuntary Movement Scale (AIMS)
Motor symptomatology associated with tardive dyskinesia (TD) assessed using the AIMS. The measure consists of 10 items with scale/scores for each item of: 0 None 1. Minimal 2. Mild 3. Moderate 4. Severe Higher ratings = higher levels of motor symptoms which is worse. This scale assesses abnormal movements for parts of the body. The total score is a sum score of items 1-10 and can be 0-40, with 40 being the most symptomatic (i.e., most extrapyramidal side effects, or worse).
Time frame: Baseline and week 4
Changes in Clinical Severity: Clinical Global Impression Scale
Changes in clinical severity over the course of treatment will be monitored using the The Clinical Global Impression Scale (CGI) consists of two items.- Severity scale (CGI-S). Severity - The first item assesses the patient's current level of mental health symptomatology compared to the clinician's experience with other patients with the same diagnosis. The scale ranges from 1. (Normal, not at all ill) 2. (Borderline mentally ill) 3. (Mildly ill) 4. (Moderately ill) 5. (Markedly ill) 6. (Severely ill) 7. (Among the most extremely ill patients) Improvement - The second item assesses how much the patient's symptomatology has changed since the last clinical visit. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse For patients this is a change measure. For control subjects, this is a one time measure. The possible score range is 1-7 with 1 being least and 7 being most symptomatic.
Time frame: Baseline and week 4 for patients; for controls this is a baseline measure only
Changes in Global Functioning: Global Assessment of Functioning (GAF)
Changes in global functioning over the course of treatment will be assessed using the Global Assessment of Functioning (GAF). Participants are rated 1-100 on their level of functioning, according to clinical observation: 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 If symptoms are present, they expected reactions to stressors 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Impairment in reality testing or communication or major impairment in several areas 21-30 Behavior influenced by delusions or hallucinations or serious impairment in communication/judgment/inability to function in almost all areas 11-20 Some danger of hurting self or others or occasionally fails to maintain minimal personal hygiene or gross impairment in communication 1-10 Persistent violence risk or lack of self-care 0 No info For patients this is a change measure. For control subjects, this is a one time measure.
Time frame: Baseline and week 4 for patients; for controls only baseline
Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire
This measure is a self-reported questionnaire which assesses for any use of the following substances within the past month prior to the initial research visit Tobacco (if the respondent indicates that they have used tobacco in the past month, they are additionally asked, "On average, how many cigarettes per day have you smoked in the past 7 days?" Alcohol, Cocaine, Marijuana, Opiates, Amphetamines, phencyclidine (PCP) Other Drugs of Abuse (if the respondent indicates they have used other drugs of abuse within the past month of the initial research visit, they are given the opportunity to "specify" which other drugs of abuse they used
Time frame: This measure is administered on Day 1 of the study.
Participants' Verbal I.Q (Intelligence Quotient) as Assessed by the WTAR (Wechsler Test of Adult Reading) to Determine Clinical Eligibility
This measure assesses a participant's verbal ability to determine whether they are cognitively able to complete the measures involved in the study. The participant will read from a list of 50 English words and the rater will record whether the pronunciation was correct on a score card for each word spoken. A standard score below the 70th percentile on this measure is indicative of an intellectual disability which would exclude a participant from being clinically and cognitively eligible to complete this study. The potential score range is 0-50. A higher score indicates better cognitive ability. There is only one total score.
Time frame: This measure is completed on Day 1 of the study.
Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale (Predominantly Right)
This measure assesses a participant's preference regarding which hand they would use to complete a specific task. They have the option to indicate whether they would use they would always or most of the time use their left, right, or both left and right hands to complete each task. This measure assesses handedness based on the amount of responses which indicate the participant is either left handed, right handed, or ambidextrous. Below we specifically report on the number of individuals who were predominantly right handed.
Time frame: This measure is completed on Day 1 of the study.
| Milestone | Patient | Control |
|---|---|---|
| Started | 13 | 13 |
| Completed | 13 | 9 |
| Not completed | 0 | 4 |
| Withdrew: Withdrawal by subject | 0 | 4 |
Dorsal Caudate (DCA) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of GABA levels, over water, in the dorsal caudate. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
| institutional units | Patient | Control |
|---|---|---|
| Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Gamma Amino Butyric Acid (GABA) Levels | -0.65 (-0.95 to -0.35) | .0037 (.00333 to .0040) |
Dorsal Caudate (DCA) Glx levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of the levels of Glx over water in the dorsal caudate. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
| institutional units | Patient | Control |
|---|---|---|
| Change in Biomarkers of Treatment Response: Dorsal Caudate (DCA) Glx (Glutamate+Glutamine) | -.28 (-.80 to 0.24) | .00221 (.00198 to .00244) |
Medial Prefrontal Cortex (MPFC) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of GABA levels, over water, in the mPFC. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
| institutional units | Patient | Control |
|---|---|---|
| Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Gamma Amino Butyric Acid (GABA) | .85 (.05 to 1.64) | .00247 (.0022 to .0025) |
Medial Prefrontal Cortex (MPFC) Glx levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response. This is a measure of glx levels, over water, in the mPFC. For patients this is a change measure. For control subjects, this is a one time measure. The values can range from 0 to infinity for controls and -infinity to infinity for patients.
| institutional units | Patient | Control |
|---|---|---|
| Change in Biomarkers Reflecting Treatment Response: Medial Prefrontal Cortex (MPFC) Glx (Glutamate+Glutamine) | 0.19 (-.54 to .93) | .00191 (.00174 to .00208) |
Memory, attention, reasoning, emotional intelligence, and verbal ability will be assessed using the MCCB before and after 4 weeks of treatment. 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 percentile score. This score can go from 0 to 100 where a higher score indicates a better performance. For patients this is a change measure. For control subjects, this is a one time measure.
| percentile score | Patient | Control |
|---|---|---|
| Changes in Neurocognitive Performance: MATRICS Consensus Cognitive Battery (MCCB) | 0.222 (0 to 34.4) | 42.9 (1.4 to 91.9) |
The WAMI Score at Baseline is a measure of socioeconomic status across countries and culture. The index scale goes from 0 (lower socioeconomic situation) to 1 (highest socioeconomic situation).
| score on a scale | Patient | Control |
|---|---|---|
| WAMI (Wealth Asset and Income) | .901 ± .179 | .982 ± .027 |
Changes in Positive and Negative Symptoms will be assessed across the treatment period using the PANSS. Participants are rated on a scale of 1. (Absent) 2. (Minimal) 3. (Mild) 4. (Moderate) 5. (Moderate severe) 6. (Severe) 7. (Extreme) to describe Positive, Negative and General symptomatology. Items from each subscale (Positive, Negative, and General) are summed for their respective scales, with lower numbers indicating less severe or absent symptomatology, and higher scores indicating more severe symptoms. A total sum of all subscales is also computed to reflect overall symptom severity. Positive Subscale: 7 items, minimum score = 7, maximum score = 49 Negative Subscale: 7 items, minimum score = 7, maximum score = 49 General Subscale: '16 items, minimum score = 16, maximum score = 112 Total Score: 30 items, minimum score = 30, maximum score = 210. For patients this is a change measure. For control subjects, this is a one time measure.
| score on a scale | Patient | Control |
|---|---|---|
| Changes in Clinical Symptomatology: Positive and Negative Syndrome Scale (PANSS) | -0.09 ± .15 | 31.89 ± 2.98 |
Motor symptomatology associated with tardive dyskinesia (TD) assessed using the AIMS. The measure consists of 10 items with scale/scores for each item of: 0 None 1. Minimal 2. Mild 3. Moderate 4. Severe Higher ratings = higher levels of motor symptoms which is worse. This scale assesses abnormal movements for parts of the body. The total score is a sum score of items 1-10 and can be 0-40, with 40 being the most symptomatic (i.e., most extrapyramidal side effects, or worse).
| score on a scale | Patient |
|---|---|
| Changes in Motor Symptomatology: Abnormal Involuntary Movement Scale (AIMS) | -.077 ± .28 |
Changes in clinical severity over the course of treatment will be monitored using the The Clinical Global Impression Scale (CGI) consists of two items.- Severity scale (CGI-S). Severity - The first item assesses the patient's current level of mental health symptomatology compared to the clinician's experience with other patients with the same diagnosis. The scale ranges from 1. (Normal, not at all ill) 2. (Borderline mentally ill) 3. (Mildly ill) 4. (Moderately ill) 5. (Markedly ill) 6. (Severely ill) 7. (Among the most extremely ill patients) Improvement - The second item assesses how much the patient's symptomatology has changed since the last clinical visit. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse For patients this is a change measure. For control subjects, this is a one time measure. The possible score range is 1-7 with 1 being least and 7 being most symptomatic.
| score on a scale | Patient | Control |
|---|---|---|
| Changes in Clinical Severity: Clinical Global Impression Scale | -0.054 ± .10 | 1 ± 0 |
Changes in global functioning over the course of treatment will be assessed using the Global Assessment of Functioning (GAF). Participants are rated 1-100 on their level of functioning, according to clinical observation: 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 If symptoms are present, they expected reactions to stressors 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Impairment in reality testing or communication or major impairment in several areas 21-30 Behavior influenced by delusions or hallucinations or serious impairment in communication/judgment/inability to function in almost all areas 11-20 Some danger of hurting self or others or occasionally fails to maintain minimal personal hygiene or gross impairment in communication 1-10 Persistent violence risk or lack of self-care 0 No info For patients this is a change measure. For control subjects, this is a one time measure.
| score on a scale | Patient | Control |
|---|---|---|
| Changes in Global Functioning: Global Assessment of Functioning (GAF) | 0.21 ± .20 | 86.4 ± 8.53 |
This measure is a self-reported questionnaire which assesses for any use of the following substances within the past month prior to the initial research visit Tobacco (if the respondent indicates that they have used tobacco in the past month, they are additionally asked, "On average, how many cigarettes per day have you smoked in the past 7 days?" Alcohol, Cocaine, Marijuana, Opiates, Amphetamines, phencyclidine (PCP) Other Drugs of Abuse (if the respondent indicates they have used other drugs of abuse within the past month of the initial research visit, they are given the opportunity to "specify" which other drugs of abuse they used
| Participants | Patient | Control |
|---|---|---|
| Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire | 6 | 4 |
This measure assesses a participant's verbal ability to determine whether they are cognitively able to complete the measures involved in the study. The participant will read from a list of 50 English words and the rater will record whether the pronunciation was correct on a score card for each word spoken. A standard score below the 70th percentile on this measure is indicative of an intellectual disability which would exclude a participant from being clinically and cognitively eligible to complete this study. The potential score range is 0-50. A higher score indicates better cognitive ability. There is only one total score.
| score on a scale | Patient | Control |
|---|---|---|
| Participants' Verbal I.Q (Intelligence Quotient) as Assessed by the WTAR (Wechsler Test of Adult Reading) to Determine Clinical Eligibility | 36.9 ± 8.43 | 43.9 ± 6.23 |
This measure assesses a participant's preference regarding which hand they would use to complete a specific task. They have the option to indicate whether they would use they would always or most of the time use their left, right, or both left and right hands to complete each task. This measure assesses handedness based on the amount of responses which indicate the participant is either left handed, right handed, or ambidextrous. Below we specifically report on the number of individuals who were predominantly right handed.
| Participants | Patient | Control |
|---|---|---|
| Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale (Predominantly Right) | 11 | 7 |
Collected over 4-6 weeks for patients, 1-2 weeks for controls. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient | 0/13 (0%) | 0/13 (0%) | 12/13 (92.3%) |
| Control | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Event | Patient | Control |
|---|---|---|
| drowsiness/sedationNervous system disorders | 8/13 | 0/13 |
| involuntary movementsMusculoskeletal and connective tissue disorders | 3/13 | 0/13 |
| HeadacheNervous system disorders | 1/13 | 0/13 |
| restlessnessMusculoskeletal and connective tissue disorders | 1/13 | 0/13 |
There are only 9 control subjects in the overall number of baseline participants as 4 of the 13 control subjects who were eligible decided to withdraw before completing the baseline procedures.
| Age, Categorical(Participants) | Patient | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 9 | 22 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Patient | Control | Total |
|---|---|---|---|
| Mean | 23.9 ± 3.3 | 26.4 ± 2.7 | 24.8 ± 3.3 |
| Sex: Female, Male(Participants) | Patient | Control | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 7 | 4 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Patient | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 1 | 7 |
| Not Hispanic or Latino | 7 | 8 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patient | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 11 |
| White | 5 | 4 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Patient | Control | Total |
|---|---|---|---|
| United States | 13 | 9 | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Sep 2017 to primary completion in May 2023, 68 months.
Results were first posted in May 2024, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Risperidone
Schizophrenia Spectrum and Other Psychotic Disorders →
Weill Medical College of Cornell University →