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Hormone Therapy
Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
Phase 2
Waitlist Available
Led By Allan L Reiss
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, and week 3
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
The purpose of this study is to determine whether the medication oxytocin is an effective and tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially appropriate behaviors and reducing social anxiety.
Eligible Conditions
- Fragile X Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, and week 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, and week 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Eye Contact/Gaze During 10 Minute Social Challenge Task
Secondary study objectives
Salivary Cortisol
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
6Treatment groups
Experimental Treatment
Group I: placebo, oxytocin 48IU, oxytocin 24IUExperimental Treatment3 Interventions
intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
Group II: placebo, oxytocin 24IU, oxytocin 48IUExperimental Treatment3 Interventions
intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
Group III: oxytocin 48IU, placebo, oxytocin 24IUExperimental Treatment3 Interventions
intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles ; intranasal oxytocin (24 international units) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
Group IV: oxytocin 48IU, oxytocin 24IU, placeboExperimental Treatment3 Interventions
intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
Group V: oxytocin 24IU, placebo, oxytocin 48IUExperimental Treatment3 Interventions
intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
Group VI: oxytocin 24IU, oxytocin 48IU, placeboExperimental Treatment3 Interventions
intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved
placebo
2010
Completed Phase 4
~6580
Oxytocin
FDA approved
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,154 Total Patients Enrolled
6 Trials studying Fragile X Syndrome
263 Patients Enrolled for Fragile X Syndrome
Allan L ReissPrincipal InvestigatorStanford University
2 Previous Clinical Trials
55 Total Patients Enrolled
2 Trials studying Fragile X Syndrome
55 Patients Enrolled for Fragile X Syndrome