Inositol for Comorbid Anxiety in Children and Adolescents With Bipolar Disorder
Status: | Not yet recruiting |
---|---|
Conditions: | Anxiety, Psychiatric, Bipolar Disorder |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 8 - 17 |
Updated: | 5/16/2018 |
Start Date: | November 1, 2018 |
End Date: | March 2019 |
Contact: | Christine McFarland |
Email: | mcfarlandce@upmc.edu |
Phone: | 412-623-6872 |
This is an open trial which seeks to determine safety and tolerability of using inositol for
children and adolescents with bipolar disorder and comorbid anxiety disorders with
exploration of efficacy and dose response.
children and adolescents with bipolar disorder and comorbid anxiety disorders with
exploration of efficacy and dose response.
Anxiety disorders are a common comorbidity among children and adolescents with bipolar
disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to
drug dependency. Inositol has shown benefit 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. A subjects 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.
disorder. Treatment with standard pharmacologic agents may worsen mood problems or lead to
drug dependency. Inositol has shown benefit 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. A subjects 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.
Inclusion Criteria:
1. DSM-V (Diagnostic and Statistical Manual-5th Ed.) diagnosis of bipolar disorder, as
determined by K-SADS (Kiddie Schedule for Affective Disorders and Schizophrenia ).
2. DSM-V diagnosis of anxiety disorder such as separation anxiety disorder, generalized
anxiety disorder, social phobia, or panic disorder, as determined by the K-SADS.
3. On a stable dose of psychotropic medications for at least one month, viz no new
medications added in the last month.
4. At least moderate severity of anxiety symptoms as determined by score on the Pediatric
Anxiety Rating Scale (PARS).
Exclusion Criteria:
1. Presence of prominent diarrhea.
2. Diagnosis of diabetes mellitus.
3. Presence of active suicidal ideation or psychosis.
4. Weight less than 20 kg.
5. Known pregnancy.
We found this trial at
1
site
3811 O'Hara Street
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Click here to add this to my saved trials