Phase
Condition
Schizotypal Personality Disorder (Spd)
Tourette's Syndrome
Learning Disorders
Treatment
RL-007
Placebo
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Diagnosis of schizophrenia, per Diagnostic and Statistical Manual (DSM) 5, with aduration of at least 6 months
Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive)
Currently treated on a single atypical antipsychotic (other than clozapine) at astable dose and clinically stable for at least 6 weeks before randomization
Clinical Global Impression - Severity score < 5.
Body mass index (BMI) <= 40.0 kg/m^2 at screening
Participant has reliable housing that is not expected to change during the studyperiod with no expected significant life events that could affect study outcomesthroughout entire study period.
Sufficient fluency in English to understand and complete study instructions andassessments
Exclusion
Key Exclusion Criteria:
History of hospitalization for medical indication or psychiatric hospitalizationwithin 3 months prior to screening.
Participants who present a serious risk of suicide, as evidenced by a) "yes" onitems 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) and meetingthese criteria within the past 6 months, or b) posing a significant suicide risk inthe Investigator's judgement.
Participants who present a risk of serious harm to others, as evidence by anyhistory within the past 2 years and any expressed homicidal ideation (with orwithout plan).
Current diagnosis of another major psychiatric disorder, intellectual disability, orany major neurological disease, brain injury, epilepsy, or severe brain trauma.
Evidence or history of significant cognitive impairment, other than associated withschizophrenia, that in the judgement of the Investigator or Sponsor would confoundinterpretation of study data or prevent safe and satisfactory completion of thestudy protocol.
Meets criteria for moderate to severe substance/drug abuse disorder (includingalcohol) per DSM-5 within the last 6 months prior to informed consent or a positivealcohol breath test or urine test for drugs of abuse at either Screening orRandomization Visits (except for benzodiazepines taken according to prescription andas an ongoing, stable regimen).
Participant has undergone electroconvulsive therapy within the past 12 months.
Study Design
Study Description
Connect with a study center
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Sofia,
BulgariaActive - Recruiting
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Plzen,
CzechiaActive - Recruiting
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Gdansk,
PolandActive - Recruiting
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Culver City, California 90230
United StatesActive - Recruiting
Collaborative Neuroscience Research
Garden Grove, California 92845
United StatesActive - Recruiting
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Lafayette, California 94549
United StatesActive - Recruiting
125 Clairemont Avenue
Oceanside, California 92056
United StatesSite Not Available
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Oceanside, California 92056
United StatesActive - Recruiting
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Orange, California 92868
United StatesActive - Recruiting
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Torrance, California 90502
United StatesActive - Recruiting
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Clermont, Florida 34711
United StatesSite Not Available
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Hialeah, Florida 33016
United StatesActive - Recruiting
125 Clairemont Avenue
Miami, Florida 33135
United StatesSite Not Available
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Miami, Florida 33135
United StatesActive - Recruiting
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Miami Lakes, Florida 33016
United StatesActive - Recruiting
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Atlanta, Georgia 30030
United StatesActive - Recruiting
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Augusta, Georgia 30912
United StatesActive - Recruiting
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Gaithersburg, Maryland 20877
United StatesActive - Recruiting
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Berlin, New Jersey 08009
United StatesActive - Recruiting
125 Clairemont Avenue
Brooklyn, New York 11235
United StatesSite Not Available
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Brooklyn, New York 11235
United StatesActive - Recruiting
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Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
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Cincinnati, Ohio 45219
United StatesActive - Recruiting
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Cleveland, Ohio 44122
United StatesActive - Recruiting
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Dallas, Texas 75231
United StatesActive - Recruiting
125 Clairemont Avenue
Houston, Texas 77074
United StatesSite Not Available
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Houston, Texas 77074
United StatesTerminated
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Everett, Washington 98201
United StatesTerminated
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