A study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome
- Conditions
- Fragile X Syndrome (FXS)MedDRA version: 14.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-004349-42-SE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
• Adults and adolescents (14 to 50)
• CGI-S of 3 (mildly ill) or more
• ABC total score of 20 or more
• Diagnosis of FXS with a confirmed FMR1 full mutation
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Have previously received treatment with another mGlu5 receptor antagonist within 18 months or RO4917523
• Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 5 times the half-life (whichever is longer)
• Any uncontrolled, unstable clinically significant psychiatric condition other than FXS that may interfere with interpretation of safety and efficacy evaluations (e.g. Attention Deficit Hyperactivity Disorder (ADHD))
• Current symptoms or presumption of psychosis or euphoria, history of catatonia, hallucinations or delusional thoughts
• History of suicidal behaviour or otherwise considered a high suicidal risk by the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method