Novel Treatment of Phobias in Children and Teenagers
A randomised controlled trial to evaluate the effects of D-Cycloserine in combination with exposure therapy, versus pill placebo and exposure therapy, in the treatment of pediatric Specific Phobia to improve symptoms of anxiety, fear and phobic avoidance.
Dr Allison Waters
70 participants
Mar 5, 2012
Interventional
Conditions
Summary
The aim of this trial is to examine whether D-Cycloserine can augment a single session of graded exposure therapy in children and adolescents with a specific phobia. D-Cycloserine is an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NDMA) agonist, which has recently been shown to facilitate fear extinction in humans and animals and has also demonstrated to improve treatment outcome when combined with exposure therapy in social phobia, acrophobia or fear of heights and OCD in adult samples. The drug has recently been successfully used to augment exposure therapy for children and adolescents with OCD.
Eligibility
Inclusion Criteria3
- Primary Diagnosis of any Anxiety Disorder
- DSM-IV-TR Specific Phobia Diagnosis
- If taking a selective-serotonin reuptake inhibitor (SSRI) medication, dose must be stable for one-month prior to study entry and remain unchanged.
Exclusion Criteria12
- Organic mental disorder
- Other medications that are contraindicated with D-Cycloserine (DCS)
- Pregnancy (this will be screened for and if sexually active be required to use birth control)
- Psychosis
- Pervasive developmental disorder
- History of seizure
- History of other serious medical condition that can be contraindicated with DCS (i.e. cardiovascular, liver, kidney, respiratory etc.)
- Serious suicidal risk
- Concurrent psychotherapy
- Current diagnosis of tuberculosis (TB)
- Currently taking medication that lowers seizure threshold (ie., clozapine)
- Impaired intelligence (IQ; likely < 70)
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Interventions
D-Cycloserine and exposure therapy versus pill placebo and exposure therapy. Participants receive one individual intensive session (3 hours) of exposure therapy. The session involves assisting participants to systematically and gradually face their fears. Half the participants will receive D-Cycloserine (either 35mg or 70mg depending on child weight) at the commencement of the exposure therapy session. Each dose is given orally in a capsule. The exposure therapy is delivered via trained psychologists.
Locations(1)
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ACTRN12612000420842