Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder (NCT02811133) | Clinical Trial Compass
WithdrawnPhase 1/2
Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Stopped: Funding terminated
United States0Started 2023-08
Plain-language 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.
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
. At least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the Pediatric Anxiety Rating Scale (PARS).
. On a stable dose of psychotropic medications for at least one month, with no major changes projected.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).
Timeframe: Weeks 1-12
2
To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using the Patient Global Index of Change Severity (PGIC-S).
Timeframe: Weeks 1-12
3
To measure the tolerability of myo-inositol, the number of participants who are able to remain on myo-inositol for the full treatment period (10-12 weeks) will be measured.
Timeframe: Weeks 1-14
4
To measure the tolerability of myo-inositol, the number of participants able to remain on the full dosage of myo-inositol for the full treatment period (10-12 weeks) will be measured.
Timeframe: Weeks 3-8
5
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.
Timeframe: Weeks 1-14
6
To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit.