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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01254045 |
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Date of registration:
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02/12/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
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Scientific title:
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Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01254045 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Allan L Reiss |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Confirmed genetic diagnosis of Fragile X (FraX) (full mutation).
2. Male (who have more serious effects due to the X chromosome nature of the disorder)
3. Age 13-29 years.
4. Parent of adolescent must be willing to sign informed consent.
5. Intelligence Quotient (IQ) > 42.
Exclusion Criteria:
1. Cardiac risk factors.
2. Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or
atypical antipsychotics.
Age minimum:
13 Years
Age maximum:
29 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Fragile X Syndrome
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Intervention(s)
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Drug: oxytocin 24IU
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Drug: placebo
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Drug: oxytocin 48IU
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Primary Outcome(s)
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Eye Contact/Gaze During 10 Minute Social Challenge Task
[Time Frame: baseline, week 2, and week 3]
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Secondary Outcome(s)
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Salivary Cortisol
[Time Frame: baseline, week 2, and week 3]
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Secondary ID(s)
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8618
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SU-11182010-7215
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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