Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Twelve male adolescent (13-24 years) subjects with confirmed genetic diagnosis of FraX (full mutation) will participate in this randomized double-blind placebo-controlled study. They will receive a dose of either 24 IU oxytocin, 48 IU oxytocin or placebo at each of three visits to the lab, with each visit spaced one week apart. The efficacy of each dose will be evaluated using behavioral, cognitive and physiological metrics. If individual subject results suggest that either of the oxytocin dosage levels (24 IU or 48 IU) is superior to placebo in the double-blind phase, a single-blind trial using the optimal dosage of oxytocin will then be administered daily for 14 days by parents at home. Subjects will then come into the lab for a final assessment on Day 30. Determination of beneficial response to oxytocin will be based on a 20% change (improvement) in behavior or test performance (see below). If both oxytocin dosage levels provide similar benefits compared to placebo, the lower dose will be chosen for the 14 day single-blind trial.

Conditions

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Fragile X Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo, oxytocin 24IU, oxytocin 48IU

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 Type EXPERIMENTAL

placebo

Intervention Type DRUG

intranasal placebo (48 international units)

oxytocin 24IU

Intervention Type DRUG

intranasal oxytocin (24 international units) and intranasal placebo (24 international units)

oxytocin 48IU

Intervention Type DRUG

intranasal oxytocin (48 international units)

oxytocin 24IU, placebo, oxytocin 48IU

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 Type EXPERIMENTAL

placebo

Intervention Type DRUG

intranasal placebo (48 international units)

oxytocin 24IU

Intervention Type DRUG

intranasal oxytocin (24 international units) and intranasal placebo (24 international units)

oxytocin 48IU

Intervention Type DRUG

intranasal oxytocin (48 international units)

oxytocin 48IU, oxytocin 24IU, placebo

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 Type EXPERIMENTAL

placebo

Intervention Type DRUG

intranasal placebo (48 international units)

oxytocin 24IU

Intervention Type DRUG

intranasal oxytocin (24 international units) and intranasal placebo (24 international units)

oxytocin 48IU

Intervention Type DRUG

intranasal oxytocin (48 international units)

oxytocin 24IU, oxytocin 48IU, placebo

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

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

intranasal placebo (48 international units)

oxytocin 24IU

Intervention Type DRUG

intranasal oxytocin (24 international units) and intranasal placebo (24 international units)

oxytocin 48IU

Intervention Type DRUG

intranasal oxytocin (48 international units)

oxytocin 48IU, placebo, oxytocin 24IU

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 Type EXPERIMENTAL

placebo

Intervention Type DRUG

intranasal placebo (48 international units)

oxytocin 24IU

Intervention Type DRUG

intranasal oxytocin (24 international units) and intranasal placebo (24 international units)

oxytocin 48IU

Intervention Type DRUG

intranasal oxytocin (48 international units)

placebo, oxytocin 48IU, oxytocin 24IU

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 Type EXPERIMENTAL

placebo

Intervention Type DRUG

intranasal placebo (48 international units)

oxytocin 24IU

Intervention Type DRUG

intranasal oxytocin (24 international units) and intranasal placebo (24 international units)

oxytocin 48IU

Intervention Type DRUG

intranasal oxytocin (48 international units)

Interventions

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placebo

intranasal placebo (48 international units)

Intervention Type DRUG

oxytocin 24IU

intranasal oxytocin (24 international units) and intranasal placebo (24 international units)

Intervention Type DRUG

oxytocin 48IU

intranasal oxytocin (48 international units)

Intervention Type DRUG

Other Intervention Names

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Syntocinon Syntocinon

Eligibility 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.