Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder

NCT02811133 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: STUDY19100221
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Anxiety Disorders; Anxiety

Keywords

inositol

Outcome Measures

Primary Outcomes (8)

• To measure the safety of myo-inositol, anxiety and mood symptoms will be measured using Clinical Global Impression Severity (CGI-S).

  This assessment rates the clinician's view of the patient's anxiety severity prior to and after initiating myo-inositol. Scores range from 0-7. Higher scores mean worse outcome.

  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).

  This scale is a parent and child report tool that evaluates participants' anxiety and assesses if there has been a decline in clinical status. Answer options are "0-None", "1-Mild", "2-Moderate", and "3-Severe" and describe symptoms of anxiety. Higher scores mean worse outcome.

  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.

  At study completion, the number of participants who remained on myo-inositol for the full 10-12 weeks will be counted.

  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.

  Participants will be titrated up to the full dose of myo-inositol by Week 3 and will remain on the full dose for 6 weeks unless they cannot tolerate the dose. At study completion, the number of participants who remained on the full-dose of myo-inositol for the full 10-12 weeks will be counted.

  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.

  This assessment is a parent and child report measure. Its scores range from 0 to 60. Higher scores are indicative of more physical and psychological symptoms and worse outcome.

  Weeks 1-14

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

  The B-SSRS probes for suicidal thoughts and behavior. The scores for both categories range from 0-5. If participants score greater than 1 on B-SSRS ideation or greater than 0 on B-SSRS behavior, then they cannot be enrolled or remain in the study. Higher scores mean worse outcome.

  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.

  A glucometer will be used to test the blood glucose levels of participants.

  Week 1 & Week 10-12

• To measure the safety of myo-inositol, physical measurements (height and weight) will be obtained.

  Myo-inositol is dosed by the weight of the participant. To make sure the participant is taking the correct dose, weight will be measured at each study visit. Height will only be measured at Week 1 to calculate BMI. Also, change in weight or BMI will be followed.

  Weeks 1-12

Secondary Outcomes (7)

• To measure the effectiveness of myo-inositol for mood symptoms, a change from baseline on the Moods and Feelings Questionnaire (MFQ) will be evaluated.

  Weeks 1-12

• To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Improvement (CGI-I) will be evaluated.

  Weeks 2-12

• To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Severity (CGI-S) will be evaluated.

  Weeks 2-12

• To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Brief Child Mania Rating Scale Parent Version (BCMRS-P) will be evaluated.

  Week 1 & Weeks 10-12

• To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Patient Global Index of Change Improvement (PGIC-I) will be evaluated.

  Weeks 2-12

Study Arms (1)

Inositol

EXPERIMENTAL

Subjects will receive inositol

Drug: Inositol

Interventions

Inositol DRUG

Subjects will receive inositol

Also known as: Myoinositol

Inositol

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Ronald M. Glick, MD: lead
• The Fine Foundation: collaborator
• Jarrow Formulas Inc: collaborator

Study Sites (1)

Child and Adolescent Bipolar Services-WPIC Bellefield

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (8)

• Benjamin J, Agam G, Levine J, Bersudsky Y, Kofman O, Belmaker RH. Inositol treatment in psychiatry. Psychopharmacol Bull. 1995;31(1):167-75.

  PMID: 7675981 BACKGROUND

• Benjamin J, Levine J, Fux M, Aviv A, Levy D, Belmaker RH. Double-blind, placebo-controlled, crossover trial of inositol treatment for panic disorder. Am J Psychiatry. 1995 Jul;152(7):1084-6. doi: 10.1176/ajp.152.7.1084.

  PMID: 7793450 BACKGROUND

• Eden Evins A, Demopulos C, Yovel I, Culhane M, Ogutha J, Grandin LD, Nierenberg AA, Sachs GS. Inositol augmentation of lithium or valproate for bipolar depression. Bipolar Disord. 2006 Apr;8(2):168-74. doi: 10.1111/j.1399-5618.2006.00303.x.

  PMID: 16542187 BACKGROUND

• Fux M, Levine J, Aviv A, Belmaker RH. Inositol treatment of obsessive-compulsive disorder. Am J Psychiatry. 1996 Sep;153(9):1219-21. doi: 10.1176/ajp.153.9.1219.

  PMID: 8780431 BACKGROUND

• Levine J. Controlled trials of inositol in psychiatry. Eur Neuropsychopharmacol. 1997 May;7(2):147-55. doi: 10.1016/s0924-977x(97)00409-4.

  PMID: 9169302 BACKGROUND

• Levine J, Barak Y, Gonzalves M, Szor H, Elizur A, Kofman O, Belmaker RH. Double-blind, controlled trial of inositol treatment of depression. Am J Psychiatry. 1995 May;152(5):792-4. doi: 10.1176/ajp.152.5.792.

  PMID: 7726322 BACKGROUND

• Palatnik A, Frolov K, Fux M, Benjamin J. Double-blind, controlled, crossover trial of inositol versus fluvoxamine for the treatment of panic disorder. J Clin Psychopharmacol. 2001 Jun;21(3):335-9. doi: 10.1097/00004714-200106000-00014.

  PMID: 11386498 BACKGROUND

• Silverstone PH, McGrath BM, Kim H. Bipolar disorder and myo-inositol: a review of the magnetic resonance spectroscopy findings. Bipolar Disord. 2005 Feb;7(1):1-10. doi: 10.1111/j.1399-5618.2004.00174.x.

  PMID: 15654927 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Anxiety Disorders

Interventions

Inositol

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Ronald Glick, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 23, 2016
• Study Start: August 1, 2023
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be shared, as deemed appropriate, starting 6 months after completion of the study for a period of 5 years.
• Access Criteria: Biomedical researcher involved in research activity in a related field and from an established research institution.

Locations

US (1)