Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Bipolar Disorder, Anxiety Disorders, Anxiety
In brief
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.
Key facts
- Study ID
- NCT02811133
- Run by
- Ronald M. Glick, MD
- People needed
- 0
- Starts
- 2023-08-01
- Expected to finish
- 2023-10-04
- Last updated by the study team
- 2023-10-06
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Child and Adolescent Bipolar Services-WPIC Bellefield — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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