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Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT02811133
Recruitment Status : Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ronald M. Glick, University of Pittsburgh

Brief Summary:
This is an open trial which seeks to determine safety and tolerability of using inositol for children and adolescents with bipolar disorder and comorbid anxiety disorders with exploration of efficacy and dose response.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Anxiety Disorders Anxiety Drug: Inositol Phase 1 Phase 2

Detailed Description:
Anxiety disorders are a common comorbidity among children and adolescents with bipolar disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to drug dependency. Inositol has shown benefit for bipolar depression in adults. This is an open multi-case control study. The investigators will enroll 20 children and adolescents ages 8-17 treated at the Child and Adolescent Bipolar Services (CABS) at Western Psychiatric Institute and Clinic. A subjects involvement will be 14 weeks, including the initial titration of the supplement, maintenance, and taper. Primary outcomes will include standard measures of mood and anxiety. Also, physiologic measures including body mass index and bedside glucose will be followed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arm Intervention/treatment
Experimental: Inositol
Subjects will receive inositol
Drug: Inositol
Subjects will receive inositol
Other Name: Myoinositol




Primary Outcome Measures :
  1. Pediatric Anxiety Rating Scale—Clinician Based (PARS) [ Time Frame: Every 2 weeks throughout study from initiation of supplement through discontinuation, with total duration of no greater than 14 weeks ]
  2. Self-Report for Childhood Related Emotional Disorders—Parent and Child Versions (SCARED) [ Time Frame: Every 2 weeks throughout study from initiation of supplement through discontinuation, with total duration of no greater than 14 weeks ]
  3. Clinical Global Impression—Severity—Clinician Based (CGI-S) [ Time Frame: Every 2 weeks throughout study from initiation of supplement through discontinuation, with total duration of no greater than 14 weeks ]
  4. Clinical Global Impression—Improvement—Clinician Based (CGI-I) [ Time Frame: Every 2 weeks throughout study from initiation of supplement through discontinuation, with total duration of no greater than 14 weeks ]

Secondary Outcome Measures :
  1. Brief Suicide Severity Rating Scale (BSSRS) [ Time Frame: Every 2 weeks throughout study from initiation of supplement through discontinuation, with total duration of no greater than 14 weeks ]
  2. Mania Rating Scale—Clinician Based (MRS) [ Time Frame: Every 2 weeks throughout study from initiation of supplement through discontinuation, with total duration of no greater than 14 weeks ]
  3. Physical Symptom Checklist (Side-effect rating scale) [ Time Frame: Every 2 weeks throughout study from initiation of supplement through discontinuation, with total duration of no greater than 14 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-V (Diagnostic and Statistical Manual-5th Ed.) diagnosis of bipolar disorder, as determined by K-SADS (Kiddie Schedule for Affective Disorders and Schizophrenia ).
  2. DSM-V diagnosis of anxiety disorder such as separation anxiety disorder, generalized anxiety disorder, social phobia, or panic disorder, as determined by the K-SADS.
  3. On a stable dose of psychotropic medications for at least one month, viz no new medications added in the last month.
  4. At least moderate severity of anxiety symptoms as determined by score on the Pediatric Anxiety Rating Scale (PARS).

Exclusion Criteria:

  1. Presence of prominent diarrhea.
  2. Diagnosis of diabetes mellitus.
  3. Presence of active suicidal ideation or psychosis.
  4. Weight less than 20 kg.
  5. Known pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811133


Contacts
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Contact: Christine McFarland 412-623-6872 mcfarlandce@upmc.edu
Contact: Ronald Glick, MD 412-623-3023 glickrm@upmc.edu

Locations
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United States, Pennsylvania
Child and Adolescent Bipolar Services-WPIC Bellefield Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ronald M. Glick
Investigators
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Principal Investigator: Ronald Glick, MD University of Pittsburgh

Publications:
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Responsible Party: Ronald M. Glick, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02811133     History of Changes
Other Study ID Numbers: 709319
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ronald M. Glick, University of Pittsburgh:
inositol

Additional relevant MeSH terms:
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Inositol
Disease
Anxiety Disorders
Bipolar Disorder
Pathologic Processes
Mental Disorders
Bipolar and Related Disorders
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs