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Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

Anxiety Clinical Trial

Official title:
Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

Clinical Trial Summary

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

Clinical Trial Description

Anxiety disorders are common comorbidities among children and adolescents with bipolar disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to drug dependency. Inositol has shown benefits 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. Participants' 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02811133
Study type Interventional
Source University of Pittsburgh
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date August 2023
Completion date October 4, 2023
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