Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine

NCT05378711 | Completed Phase 2

• 1 other identifier: 13-718F
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The Department of Counseling, Educational Psychology, and Special Education and the Department of Psychiatry at Michigan State University have coordinated efforts to provide a diagnostic and treatment investigation for children, ages seven to eighteen, with Selective Mutism. The purpose of this study is to examine the utility of fluoxetine for the treatment of this debilitating disorder. Fluoxetine is expected to improve social anxiety and selective mutism symptomology.

Conditions

Selective Mutism; Social Anxiety

Keywords

Selective Mutism; Social Anxiety; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• Selective Mutism Questionnaire (Change Over 15 Weeks)

  2 times per week for 15 weeks

Secondary Outcomes (6)

• Multidimensional Anxiety Scale for Children - 2nd Edition (Change Over 15 Weeks)

  2 times per week for 15 weeks

• Direct Behavior Ratings - Parent (Change Over 15 Weeks)

  Parent (3 times per week for 15 weeks); Teacher (5 times per week for 15 weeks)

• Clinical Global Impression (Change Over 15 Weeks)

  Parent and Teacher (2 times per week for 15 weeks); Psychiatrist (biweekly for 15 weeks)

• Side Effects Form for Children and Adolescents - Adapted (Change Over 15 Weeks)

  biweekly for 15 weeks

• Parent - Young Mania Rating Scale (Change Over 15 Weeks)

  2 times per week for 15 weeks

Other Outcomes (1)

• Treatment Integrity Form

  Daily for 15 weeks

Study Arms (1)

Fluoxetine

EXPERIMENTAL

Children will receive an introductory dose and therapeutic dose of fluoxetine at various time points in the study. Onset of fluoxetine is determined by assignment to a pre-determined randomized treatment schedule.

Drug: Fluoxetine

Interventions

Fluoxetine DRUG

Children will receive a placebo or fluoxetine at different times dependent upon random assignment to a treatment schedule.

Also known as: Prozac

Fluoxetine

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female from seven to seventeen years of age at their last birthday
• Meet DSM-IV-TR criteria for selective mutism
• No history of medication treatment for selective mutism
• Child has an immediate biological family member who is diagnosed with an anxiety disorder or has experienced symptoms of an anxiety disorder at some point in time
• Child has received 10 weeks of an evidence-based psychosocial treatment
• Child has never had a negative reaction to a psychopharmacological medication
• Child exhibits symptoms of social anxiety

You may not qualify if:

• Child is diagnosed with a speech condition, mental retardation, pervasive developmental disorder, or schizophrenia
• Child is an English language learner or from a different culture than the culture predominately represented within his or her school
• Child is taking or has taken any kind of a psychopharmacological medication (e.g., SSRI, MAO-I, stimulant, etc.)
• Child has a medical illness that may be complicated through the use of a psychopharmacological treatment

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Michigan State University Psychiatry Clinic

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Mutism

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Jed Magen, DO

  Michigan State University

  PRINCIPAL INVESTIGATOR

• John Carlson, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

• Justin Barterian, MA

  Michigan State University

  PRINCIPAL INVESTIGATOR

• Joel Sanchez, MD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Masking Details: Participants serve as their own controls by being randomly assigned to switch from placebo to active medication at staggered start dates per single case design methodology.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair - Department of Psychiatry

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 18, 2022
• Study Start: January 1, 2014
• Primary Completion: May 30, 2015
• Study Completion: May 30, 2015
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)