This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
185
placebo to RO4917523 orally once a day for 12 weeks
0.5 mg orally once a day for 12 weeks
1.5 mg orally once a day for 12 weeks
Change in Anxiety Depression and Mood Scale (ADAMS) total score
Time frame: 12 weeks
Safety (incidence of adverse events)
Time frame: 12 weeks
Change in Social Responsiveness Scale (SRS)
Time frame: 12 weeks
Change in Clinical Global Impressions Scale - Improvement (CGI-I)
Time frame: 12 weeks
Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S)
Time frame: 12 weeks
Change in Aberrant Behavior Checklist total score
Time frame: 12 weeks
Change in Aberrant Behavior Checklist factor scores
Time frame: 12 weeks
Change in Anxiety Depression and Mood Scale (ADAMS) factor scores
Time frame: 12 weeks
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Phoenix, Arizona, United States
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Long Beach, California, United States
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Sacramento, California, United States
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Aurora, Colorado, United States
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Washington D.C., District of Columbia, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
...and 41 more locations