Clinical trial NCT02811133: Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Official title: Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Bipolar Disorder
Anxiety Disorders
Anxiety
Keywords: inositol
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Fine Foundation
name: Jarrow Formulas Inc
First posted: 2016-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Anxiety disorders are common comorbidities among children and adolescents with bipolar disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to drug dependency. Inositol has shown benefits for bipolar depression in adults. This is an open multi-case control study. The investigators will enroll 20 children and adolescents ages 8-17 treated at the Child and Adolescent Bipolar Services (CABS) at Western Psychiatric Institute and Clinic. Participants' involvement will be 14 weeks, including the initial titration of the supplement, maintenance, and taper. Primary outcomes will include standard measures of mood and anxiety. Also, physiologic measures including body mass index and bedside glucose will be followed.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. At least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the Pediatric Anxiety Rating Scale (PARS).
4. On a stable dose of psychotropic medications for at least one month, with no major changes projected.

Exclusion Criteria:

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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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.
timeFrame: Week 1 & Week 10-12
measure: To measure the safety of myo-inositol, physical measurements (height and weight) will be obtained.
timeFrame: Weeks 1-12
Secondary outcomes:
measure: To measure the effectiveness of myo-inositol for mood symptoms, a change from baseline on the Moods and Feelings Questionnaire (MFQ) will be evaluated.
timeFrame: Weeks 1-12
measure: To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Improvement (CGI-I) will be evaluated.
timeFrame: Weeks 2-12
measure: To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on Clinical Global Impression Severity (CGI-S) will be evaluated.
timeFrame: Weeks 2-12
measure: 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.
timeFrame: Week 1 & Weeks 10-12
measure: 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.
timeFrame: Weeks 2-12
measure: To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Patient Global Index of Change Severity (PGIC-S) will be evaluated.
timeFrame: Weeks 1-12
measure: To measure the effectiveness of myo-inositol for anxiety symptoms, a change from baseline on the Self-Report for Childhood Related Emotional Disorders (SCARED) will be evaluated.
timeFrame: Weeks 1-12
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Child and Adolescent Bipolar Services-WPIC Bellefield
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ronald Glick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benjamin J, Agam G, Levine J, Bersudsky Y, Kofman O, Belmaker RH. Inositol treatment in psychiatry. Psychopharmacol Bull. 1995;31(1):167-75.
citation: 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.
citation: 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.
citation: 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.
citation: Levine J. Controlled trials of inositol in psychiatry. Eur Neuropsychopharmacol. 1997 May;7(2):147-55. doi: 10.1016/s0924-977x(97)00409-4.
citation: 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.
citation: 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.
citation: 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.