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 range8 Years – 17 Years

SexALL

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

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

What they're measuring

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

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

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

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

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

To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit.

Timeframe: Weeks 1-12

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.

Trial details

NCT IDNCT02811133

SponsorRonald M. Glick, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-04

View on ClinicalTrials.gov More Bipolar Disorder trials

Who can participate

Age range8 Years – 17 Years

SexALL

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

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

What they're measuring

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

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

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

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

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

To measure the safety of myo-inositol, the Brief Suicide Severity Rating Scale (B-SSRS) will be measured at each visit.

Timeframe: Weeks 1-12

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.