RecruitingPhase 2ACTRN12612000420842

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.


Sponsor

Dr Allison Waters

Enrollment

70 participants

Start Date

Mar 5, 2012

Study Type

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

Sex: Both males and femalesMin Age: 7 YearssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called D-Cycloserine can make a single session of exposure therapy work better for children and teenagers with a specific phobia (an intense fear of something like heights, animals, or needles). D-Cycloserine is normally an antibiotic for tuberculosis, but research has shown it may help the brain learn to be less afraid. The study involves one session of guided exposure to the feared object or situation, with participants receiving either the study drug or a placebo pill. You may be eligible if: - You are between 7 and 17 years old - You have been diagnosed with a specific phobia - You have an anxiety disorder as your primary diagnosis - If you are already on an SSRI medication, the dose has been stable for at least one month You may NOT be eligible if: - You have an organic brain condition, psychosis, or pervasive developmental disorder - You have a history of seizures - You are pregnant or sexually active without using birth control - You are currently receiving other psychotherapy - You have active tuberculosis or are taking medication that lowers the seizure threshold (such as clozapine) - You have a significant medical condition affecting the heart, liver, kidneys, or lungs - You have a low IQ (below approximately 70) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 partici

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)

Australia

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ACTRN12612000420842


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