Selective MutismPhase 2NCT05378711
Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine
A Phase 2 study testing Fluoxetine in people with Selective Mutism and Social Anxiety, run by Michigan State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Selective Mutism, Social Anxiety
- What is being tested?
- Fluoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2014to 30 May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University Psychiatry Clinic
East Lansing, Michigan, 48824
About this study
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.
Read the detailed description
Children with selective mutism (SM) are at risk for current and continuing academic and socio-emotional difficulties. Unfortunately, this issue is complicated by the fact these children often respond poorly to psychosocial intervention. This leaves parents with the overwhelming decision to attempt a trial of medication regardless of the little available data on the evidence base of this approach. Despite the paucity of research, psychiatrists are prescribing fluoxetine for children with SM "off label", as the Food and Drug Administration (FDA) has yet to approve fluoxetine for this indication. This study blends the psychopharmacological expertise of psychiatrists with the mental health, systems, and psychological evaluation expertise of school psychologists to identify an appropriate psychopharmacological solution for children and adolescents with this debilitating disorder. To that end, this study will examine the utility of fluoxetine for the treatment of five children and adolescents, ages seven to eighteen, diagnosed with SM through the use of a non-concurrent multiple-baseline single-case design with a single-blind placebo-controlled procedure. Treatment effectiveness will be evaluated by visual analysis of the data, the Wampold and Worsham multiple-baseline design randomization test, and the Kendall's Tau + Mann-Whitney U effect size. Multiple methods of assessment including standardized measures, such as the Selective Mutism Questionnaire (SMQ), and behavior ratings, such as Direct Behavior Ratings (DBRs), will be used to gather baseline and treatment data. Multiple informants (i.e., parents, teachers, and psychiatrists) will provide information on treatment effect across settings (i.e., school and community). Information regarding adverse effects associated with fluoxetine treatment including a measure of behavioral disinhibition, parental acceptance of the fluoxetine intervention, and compliance with taking the medication will also be gathered.
- Conditions
- Selective Mutism, Social Anxiety
- Being tested
- Fluoxetine
- Keywords
- Selective Mutism, Social Anxiety, Children, Adolescents
- Medical subject headings
- Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
Children will receive a placebo or fluoxetine at different times dependent upon random assignment to a treatment schedule.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective Mutism Questionnaire (Change Over 15 Weeks)
Measured: 2 times per week for 15 weeks
Secondary outcomes (6)
Multidimensional Anxiety Scale for Children - 2nd Edition (Change Over 15 Weeks)
Measured: 2 times per week for 15 weeks
Direct Behavior Ratings - Parent (Change Over 15 Weeks)
Measured: Parent (3 times per week for 15 weeks); Teacher (5 times per week for 15 weeks)
Clinical Global Impression (Change Over 15 Weeks)
Measured: 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)
Measured: biweekly for 15 weeks
Parent - Young Mania Rating Scale (Change Over 15 Weeks)
Measured: 2 times per week for 15 weeks
Treatment Evaluation Questionnaire - Parent
Measured: End of Study (after 15 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jan 2014
- Primary completion30 May 2015
- Study completion30 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective MutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jed Magen, Michigan State University
- Investigators
- Jed Magen, DO, Principal investigator, Michigan State UniversityJohn Carlson, PhD, Principal investigator, Michigan State UniversityJustin Barterian, MA, Principal investigator, Michigan State UniversityJoel Sanchez, MD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378711
- Sponsor's protocol ID
- 13-718F
- Status last verified
- May 2022
- First submitted
- 19 May 2014
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine
- ClinicalTrials.gov ID
- NCT05378711
- Acronym / sponsor ID
- 13-718F
- Conditions
- Selective Mutism, Social Anxiety
- Keywords
- Selective Mutism, Social Anxiety, Children, Adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 May 2015 (actual)
- Study completion
- 30 May 2015 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children with selective mutism (SM) are at risk for current and continuing academic and socio-emotional difficulties. Unfortunately, this issue is complicated by the fact these children often respond poorly to psychosocial intervention. This leaves parents with the overwhelming decision to attempt a trial of medication regardless of the little available data on the evidence base of this approach. Despite the paucity of research, psychiatrists are prescribing fluoxetine for children with SM "off label", as the Food and Drug Administration (FDA) has yet to approve fluoxetine for this indication. This study blends the psychopharmacological expertise of psychiatrists with the mental health, systems, and psychological evaluation expertise of school psychologists to identify an appropriate psychopharmacological solution for children and adolescents with this debilitating disorder. To that end, this study will examine the utility of fluoxetine for the treatment of five children and adolescents, ages seven to eighteen, diagnosed with SM through the use of a non-concurrent multiple-baseline single-case design with a single-blind placebo-controlled procedure. Treatment effectiveness will be evaluated by visual analysis of the data, the Wampold and Worsham multiple-baseline design randomization test, and the Kendall's Tau + Mann-Whitney U effect size. Multiple methods of assessment including standardized measures, such as the Selective Mutism Questionnaire (SMQ), and behavior ratings, such as Direct Behavior Ratings (DBRs), will be used to gather baseline and treatment data. Multiple informants (i.e., parents, teachers, and psychiatrists) will provide information on treatment effect across settings (i.e., school and community). Information regarding adverse effects associated with fluoxetine treatment including a measure of behavioral disinhibition, parental acceptance of the fluoxetine intervention, and compliance with taking the medication will also be gathered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Experimental | Drug: FluoxetineChildren 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetineAlso: ProzacChildren will receive a placebo or fluoxetine at different times dependent upon random assignment to a treatment schedule. | Drug | Fluoxetine |
Primary outcome
Selective Mutism Questionnaire (Change Over 15 Weeks)
Time frame: 2 times per week for 15 weeks
6 secondary outcomes
Multidimensional Anxiety Scale for Children - 2nd Edition (Change Over 15 Weeks)
Time frame: 2 times per week for 15 weeks
Direct Behavior Ratings - Parent (Change Over 15 Weeks)
Time frame: Parent (3 times per week for 15 weeks); Teacher (5 times per week for 15 weeks)
Clinical Global Impression (Change Over 15 Weeks)
Time frame: 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)
Time frame: biweekly for 15 weeks
Parent - Young Mania Rating Scale (Change Over 15 Weeks)
Time frame: 2 times per week for 15 weeks
Treatment Evaluation Questionnaire - Parent
Time frame: End of Study (after 15 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
Related trials for Selective Mutism
Recruiting
VR Homework Exercises for Selective Mutism Treatment
Selective Mutism, Anxiety Disorder of Childhood
Recruiting
Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jed Magen, DO principal investigator
Michigan State University
John Carlson, PhD principal investigator
Michigan State University
Justin Barterian, MA principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxetine in people with Selective Mutism and Social Anxiety, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective Mutism Questionnaire (Change Over 15 Weeks) (time frame: 2 times per week for 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.