Phase 3
N=62
Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00194012 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Young Mania Rating Scale (YMRS) — 24.8; 21.6 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (Drug); Placebo (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Young Mania Rating Scale (YMRS) |
5.73; 7.57 | — |
| PRIMARY Young Mania Rating Scale (YMRS) |
5.73; 7.57 | — |
| PRIMARY Young Mania Rating Scale (YMRS) |
5.73; 7.57 | — |
| SECONDARY Children's Depression Rating Scale-Revised (CDRS-R ) |
33.7; 30.3 | — |
| SECONDARY CDRS-R Children's Depression Rating Scale-Revised |
21.5; 21.7 | — |
| SECONDARY CDRS-R Children's Depression Rating Scale-Revised |
21.5; 21.7 | — |
| SECONDARY Children's Global Assessment Scale (CGAS) |
71.47; 69.72 | — |
| SECONDARY Children's Global Assessment Scale (CGAS) |
71.47; 69.72 | — |
| SECONDARY Children's Global Assessment Scale (CGAS) |
71.47; 69.72 | — |
| SECONDARY Clinical Global Impressions Scale (CGI-Severity) |
1.85; 1.89 | — |
| SECONDARY Clinical Global Impressions Scale (CGI-Severity) |
1.85; 1.89 | — |
| SECONDARY Clinical Global Impressions Scale (CGI-Severity) |
1.85; 1.89 | — |
| SECONDARY Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) |
18.1; 28.1 | — |
| SECONDARY Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) |
18.1; 28.1 | — |
| SECONDARY Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) |
18.1; 28.1 | — |
Summary
The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder.
Eligibility Criteria
Inclusion Criteria
- Outpatients ages 5-17 years (inclusive)
- Patients, who in the investigator's opinion have substantial symptoms of mania, depression, or both within the past 2 weeks such that treatment with a pharmacological agent is warranted
- Currently meets Diagnostic Statistical Manual of Mental Disorders (DSM-IV) criteria for either cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment, Present and Lifetime Version (K-SADS-Present and Lifetime (PL) supplemented with sections from the Washington University K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist.
- Offspring of a parent with a bipolar spectrum disorder (based on the results of either the Mini International Neuropsychiatric Interview (MINI)(Sheehan et al., 1998) or the Family History Method (FH-RDC)(Andreasen et al., 1977)
- Has another first or second degree relative with a mood disorder determined by the results of either the MINI or the FH-RDC
- Has participated in at least 4 sessions of psychotherapy specifically focused on the symptoms/management of pediatric mood disorder and continues to have clinically significant symptomatology
Exclusion Criteria
- Patients who have a history of intolerance to APZ at doses of 0.1mg/kg/day
- Patients who have experienced a manic episode with documented treatment with APZ monotherapy at a dose of 0.2 mg/kg/day
- Patients with an active neurological/medical disorder for which treatment with APZ would be contraindicated
- Patients with clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome or other pervasive developmental disorder
- Patients with clinical evidence of mental retardation
- Patients who are known to be allergic or hypersensitive to aripiprazole
- Patients who are unable to swallow pills/capsules
- Patients for whom the need for hospitalization during the course of the study appears likely
- Patients who have started a new psychotherapeutic intervention within less than 4 weeks of randomization
- Patients who have a general medical or neurological condition (including clinically significant abnormalities on screening laboratories) that may be considered to be the etiology of the patient's mood disorder
- Patients who have a general medical or neurological condition for which treatment with an atypical antipsychotic would be contraindicated (e.g. tardive dyskinesia)
- Patients who have a general medical or neurological condition that could interfere with the interpretation of clinical response to APZ treatment
- Patients taking psychotropic agents (other than psychostimulants) within one week of baseline (2 weeks for fluoxetine; 3 days for psychostimulants)
- Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months
- Has met DSM-IV criteria for drug/alcohol abuse or dependence within the past 6 months
- Females who are currently pregnant or lactating
- Sexually active females, who in the investigators' opinion are not using an adequate form of birth control
Data sourced from ClinicalTrials.gov (NCT00194012). 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.