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Inositol for 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

Study Summary

This trial is testing if inositol is a safe and tolerated treatment for children and adolescents with bipolar disorder and comorbid anxiety disorders. They will also explore if inositol is an effective treatment and what dose works best.

Eligible Conditions
  • Bipolar Disorder
  • Anxiety Disorders
  • Anxiety

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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).
+5 more
Secondary outcome measures
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.
+4 more

Side effects data

From 2019 Phase 4 trial • 69 Patients • NCT01396486
14%
Nausea/Vomit/Diarrhea
5%
Increased Appetite
5%
Cold/Infection/Allergy
5%
Insomnia
5%
Pulmonary
5%
Earache
5%
Thirsty
5%
Neurological
5%
Headache
5%
Tics
5%
Musculoskeletal
5%
Autonomic
5%
Dizzy/Lightheaded
5%
Agitated with Homicidal Statements
100%
80%
60%
40%
20%
0%
Study treatment Arm
Omega-3/Placebo
Omega-3/Inositol
Placebo/Inositol

Trial Design

1Treatment groups
Experimental Treatment
Group I: InositolExperimental Treatment1 Intervention
Subjects will receive inositol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inositol
2012
Completed Phase 4
~140

Find a Location

Who is running the clinical trial?

Ronald M. Glick, MDLead Sponsor
Jarrow Formulas IncIndustry Sponsor
5 Previous Clinical Trials
648 Total Patients Enrolled
The Fine FoundationUNKNOWN

Media Library

Inositol (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02811133 — Phase 1 & 2
Bipolar Disorder Research Study Groups: Inositol
Bipolar Disorder Clinical Trial 2023: Inositol Highlights & Side Effects. Trial Name: NCT02811133 — Phase 1 & 2
Inositol (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02811133 — Phase 1 & 2
~0 spots leftby Jun 2025
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