Phase
Condition
Tourette's Syndrome
Post-traumatic Stress Disorders
Schizotypal Personality Disorder (Spd)
Treatment
Oral risperidone; QUAR F1/2, Dose 1 - Gluteal
Oral risperidone; QUAR F1/2, Dose 2 - Gluteal
Oral risperidone; QUAR F1/2, Dose 3 - Gluteal
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Capable of providing informed consent.
Male or female aged ≥ 18 years to < 65 years with BMI ≥17.0 to ≤35.0 kg/m2
Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria.
Medically stable over the last month, and psychiatrically stable without significantsymptom exacerbation over the last three months based on the investigator's judgment
currently taking oral risperidone as maintenance therapy
Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severityof Illness (CGI-S)
If a sexually active female of childbearing potential, using a medically acceptedmethod of birth control.
Exclusion
Exclusion Criteria:
Presence of an uncontrolled, unstable, clinically significant medical condition thatin the opinion of the investigator could interfere with the interpretation of safetyand PK evaluations
If female, a positive serum pregnancy test, or planning to become pregnant betweensigning informed consent and 1 month after the last dose of study drug or isbreastfeeding a child.
History of neuroleptic malignant syndrome and current or past history of clinicallysignificant tardive dyskinesia.
The participant has a primary diagnosis other than schizophrenia diagnosis that isprimarily responsible for current symptoms and functional impairment
Positive test result for drugs of abuse or alcohol unless the positive finding canbe accounted for by documented prescription use.
In the investigator's opinion, at imminent risk of committing self-harm or harm toothers.
Unwilling to discontinue any of the prohibited medications prior to the baselinevisit or unable to safely washout such medication without significantdestabilization or increased risk of self-harm (suicide).
Receipt study drug in another investigational study in the last 90 days.
Current participation in any other clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site
Amman,
JordanActive - Recruiting
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