Acoustic Neuromodulation (ANM) for Youth With Anxiety Disorders

Stopped early · Not applicable · Has a placebo group

Conditions studied: Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia

In brief

The acoustic neuromodulation trial (ANM-T) is a two-phase, single-site, pilot randomized clinical trial examining the feasibility of completing a larger scale efficacy study of a novel treatment of non-linear modulated acoustic stimuli to reduce anxiety severity in youth with anxiety disorders. The primary objective is to establish the feasibility of a blinded randomized controlled trial of ANM for childhood anxiety disorders.

Key facts

Study ID

NCT02572973

Run by

Weill Medical College of Cornell University

People needed

6

Starts

2014-07-01

Expected to finish

2016-04-01

Last updated by the study team

2019-01-14

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages 7-17 years inclusively (i.e., must be at least 7 years) at the point of consent
• Primary DSM 5 diagnosis of SepAD, SocAD, or GAD on the ADIS-RLV (Gate B).
• Anxiety severity of moderate or greater (CGI-S >3 and functional impairment (CGAS score of \<60) (Gate C).

You may not qualify if…

• Estimated child Full Scale IQ < 80, as measured by the vocabulary and block design subtests of the WISC-III) (Gate B). If a potential subject has a verified IQ score in the three years prior to enrollment as measured by the WISC-III, IIIR, K-ABC, or Stanford-Binet no IQ assessment is required.
• Child meets criteria for current primary or co-primary Panic Disorder, OCD, PTSD, conduct disorder or substance abuse (Gate B).
• Child meets criteria for Major Depressive Disorder at greater severity than anxiety disorder (Gate B). d. Subjects with the following lifetime psychiatric disorders will be excluded: bipolar disorder, PDD (Asperger's, autism), MDD with psychosis, schizophrenia, and schizoaffective disorder (Gate B).
• Current use of psychotropic medication or clinical indication for use of psychotropic medication (except for youth entering on a stable psychostimulant regimen for ADHD) (Gates A, B).
• Recent treatment with psychotropic medication within 6 weeks of study entry for fluoxetine, within 2 weeks for other SSRIs, and within 4 weeks for neuroleptics (Gates A, B).
• Child has failed an adequate trial of CBT for anxiety within the previous 2 years (at least 10 treatment sessions over a period of less than 1 year conducted by a licensed provider of CBT) (Gates A, B).
• Child has a major neurological disorder, a major medical illness or hearing impairment that requires a prohibited episodic or chronic systemic medication or that would interfere with participation in the study (e.g., frequent hospitalizations, frequent school absences) (Gates A, B).
• Child is pregnant as indicated by history or a positive pregnancy test at Gate B. Sexually active girls must agree to use an effective form of birth control, either hormonal (BCP, Depo-Provera or Norplant), spermicide (foam or vaginal suppository) or a barrier method (condoms, diaphragm, cervical cap) or a combination of barrier/spermicide contraception in order to participate in the study.
• Child poses a significant risk for dangerousness to self or to others (Gates A, B, C).
• Child or parent is non-English speaking (unable to complete measures, IE ratings or treatment without the assistance of a translator) (Gates A, B). NYSPI and UCLA may recruit Spanish speaking subjects.
• Child is a victim of ongoing or previously undisclosed child abuse requiring new department of social service report or ongoing department of social service supervision (Gate B).
• Child, for any reason, has missed more than 50% of school days in the 2 months preceding randomization. Home schooling does not require exclusion from the study under this exclusion criterion. Ambiguous cases are referred to Caseness Panel to avoid truncating the severity range differently across sites (Gates A, B).
• Child has a history of seizures

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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