Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

Phase 1 & 2

Waitlist Available

Led By Ronald Glick, MD

Research Sponsored by Ronald M. Glick, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 & week 10-12

Awards & highlights

No Placebo-Only Group

Summary

This trial tests inositol, a sugar-like supplement, on young individuals with bipolar disorder and anxiety. The goal is to see if it can safely improve mood and reduce anxiety by helping brain chemicals work better. Inositol has been studied for its potential benefits in various psychiatric disorders, including depression, anxiety, and bipolar disorder.

Eligible Conditions

Bipolar Disorder
Generalized Anxiety Disorder
Anxiety Disorders
Anxiety

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 & week 10-12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 & week 10-12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 & week 10-12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To measure the safety and tolerability of myo-inositol, a change from baseline on the Physical Symptom Checklist (Side Effect Rating Scale) will be measured.

To measure the safety of myo-inositol, a fingerstick blood test will be done to measure glucose levels at the first and final study visits.

To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).

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Secondary study objectives

Anxiety

To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Improvement (CGI-I) will be evaluated.

To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Severity (CGI-S) will be evaluated.

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