Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

Ronald M. Glick, MD

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Bipolar Disorder; Anxiety; Anxiety Disorders

Treatments: Drug: Inositol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02811133

STUDY19100221

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Evidence in the medical record confirming the DSM-V diagnosis of bipolar disorder. If this documentation is not in the record, then the appropriate sections of K-SADS will be administered to confirm the diagnosis.
2. Evidence in the medical record confirming the DSM-V diagnosis of anxiety disorder including; separation anxiety disorder, generalized anxiety disorder, and/or social phobia. If this documentation is not present or is more than 2 years old, then the appropriate section of the K-SADS will be administered to confirm diagnosis.
3. At least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the Pediatric Anxiety Rating Scale (PARS).
4. On a stable dose of psychotropic medications for at least one month, with no major changes projected.

Exclusion criteria

1. Presence of prominent diarrhea.
2. Diagnosis of diabetes mellitus.
3. Presence of active suicidal ideation and behavior or psychosis. B-SSRS ideation score greater than 1. B-SSRS behavior score greater than 0.
4. Weight less than 20 kg.
5. Known pregnancy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Inositol

Experimental group

Description:

Subjects will receive inositol

Treatment:

Drug: Inositol