N/A
N=62
Uridine Adolescent Bipolar Depression Randomized Controlled Trial
Bipolar Disorder · Bipolar Depression · Manic Depression
Bottom Line
View on ClinicalTrials.gov: NCT01805440 ↗Enrolled (actual)
62
Serious AEs
2.8%
Results posted
Mar 2018
Primary outcome: Primary: Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS). — 1.5731; 1.6557; 1.6051; 1.6738 Brain GLX/Cr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Uridine (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS). |
1.5731; 1.6557; 1.6051; 1.6738; 1.6121; NA | — |
| PRIMARY Change in Children's Depression Rating Scale-Revised (CDRS-R) Score. |
59.05; 58.18; 21.31; 45.67; 36.76; NA | — |
| SECONDARY Columbia-Suicide Severity Rating Scale (C-SSRS) |
0.6875; 0.5882; 0; 0.5; 0.4706; NA | — |
Summary
This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for depressed adolescents with bipolar disorder (i.e. "bipolar depression"). Participants initially randomized to placebo who complete the 6-week protocol will be offered 6 months of open-label uridine treatment and follow-up. Participants initially randomized to uridine will be offered the open-label treatment as well.
Eligibility Criteria
Inclusion Criteria For Bipolar Disorder Participants:
- Participants under 18 years of age must be able to provide assent, and have the permission of a parent or guardian. Participants 18 years of age or older must be able to provide informed consent.
- Participants must be between the ages of 13 and 21 years.
- Participants must meet DSM criteria for Bipolar Disorder (Type I, II, or NOS), with current mood state depressed for at least 2 weeks.
- Participants must have a current Children's Depression Rating Scale-Revised (CDRS-R) score of 45 or greater, and/or a Montgomery/Asberg Depression Rating Scale (MADRS) score of 25 or greater.
Inclusion Criteria For Healthy Comparison Participants:
- Participants under 18 years of age must be able to provide assent, and have the permission of a parent or guardian. Participants 18 years of age or older must be able to provide informed consent.
- Participants must be between the ages of 13 and 21 years.
- Participants must not meet any DSM-IV criteria for a psychiatric illness or substance use disorder
Exclusion Criteria
- Participants must not meet DSM criteria for a primary psychotic disorder, a developmental disorder or substance use disorder.
- Participants must not be at high risk for suicidal or homicidal actions.
- Participants must not be pregnant or breastfeeding.
- Participants must not have a contraindication to magnetic resonance imaging (e.g. ferromagnetic implant, or claustrophobic anxiety).
- Incarcerated persons are excluded, because this study is not approved for Research Involving Prisoners.
Data sourced from ClinicalTrials.gov (NCT01805440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.