Phase
Condition
Tourette's Syndrome
Psychosis
Schizotypal Personality Disorder (Spd)
Treatment
N/AClinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Main Inclusion Criteria:
The patient has schizophrenia, diagnosed according to DSM-IV-TR®.
The patient has a CGI-S score from mildly ill to markedly ill at the Screening andBaseline Visit(s).
The patient is in need of a change in the current antipsychotic treatment and in thejudgement of the investigator the patient would benefit from an extended treatmentwith a once-monthly formulation.
The patient agrees to protocol-defined use of effective contraception.
Exclusion
Main Exclusion Criteria:
The patient has any current psychiatric disorder or Axis I disorder (DSM-IV® criteria)other than schizophrenia established as the primary diagnosis.
The patient is experiencing acute exacerbation of psychotic symptoms at the ScreeningVisit or between the Screening and Baseline Visits.
The patient in the investigator's judgment has shown significant intolerance and/orlack of efficacy to oral aripiprazole, paliperidone or risperidone.
The patient is at significant risk of harming himself/herself or others according tothe investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
The patient has a history of neuroleptic malignant syndrome.
The patient has or has had significant medical condition that would expose him or herto an undue risk of a significant adverse event or interfere with assessments ofsafety or efficacy during the course of the study including, but not limited toneurological, hepatic, renal, metabolic, haematological, immunological,gastrointestinal, pulmonary, or cardiovascular disorders.
The patient has a disease or takes medication that could, in the investigator'sopinion, interfere with the assessments of safety, tolerability, or efficacy, orinterfere with the conduct or interpretation of the study.
The patient is, in the investigator's opinion, unlikely to comply with the protocol oris unsuitable for any reason.
Study Design
Connect with a study center
US002
Los Angeles, California 90660
United StatesSite Not Available
US006
San Diego, California 92102
United StatesSite Not Available
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