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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you enumerate other experiments conducted regarding Inositol?

"Presently, there are 7 scientific investigations into the efficacy of Inositol. Of those trials, 1 is in its final phase. These studies span across 7 sites with a concentration in Boston Massachusetts."

Answered by AI

Could I be eligible to partake in the research endeavor?

"Prospective participants of this clinical trial should present with anxiety disorders and fall within the 8-17 age range. This is a limited recruitment, expecting no more than 20 enrollees."

Answered by AI

Is this trial currently enrolling participants?

"As seen on clinicaltrials.gov, the enrolment for this trial is currently paused; it was first posted on November 1, 2022 and has been modified most recently as of November 4th, 2022. Despite its temporary suspension in recruitment, 1512 other studies are actively searching for individuals to take part in them."

Answered by AI

How many participants are engaged in this experiment?

"At the present moment, this trial has ceased to accept new participants. Initially posted on November 1st 2022 and last updated four days later, these openings have filled up. Nonetheless, those hoping for an alternative should be aware that there are 1505 clinical trials related to anxiety disorders actively recruiting patients as well as 7 studies involving Inositol still accepting applicants."

Answered by AI

Can individuals of 25 years or older participate in this research?

"To be considered for enrollment, participants must fall into the 8 to 17 year-old age bracket. Currently, there are 372 clinical trials specifically tailored towards minors and 1033 studies targeting seniors."

Answered by AI

What are the desired results of this medical experiment?

"During Weeks 1-14, this trial will primarily assess the safety and tolerability of myo-inositol through changes in patients' physical symptom checklist. The efficacy of myo-inositol for treating anxiety symptoms is measured with three different assessments: Brief Child Mania Rating Scale Parent Version (BCMRS-P), Self Report for Childhood Related Emotional Disorders (SCARED) and Clinical Global Impression Severity (CGI-S). Each assessment utilizes a Likert type scale to score from 0 - 30, 82 or 7 respectively; depending on which evaluation tool is utilized."

Answered by AI
~0 spots leftby Apr 2025