Study of Aripiprazole (Abilify) in Children With Symptoms of Mania

Condition(s) targeted: Bipolar Disorder

Intervention: abilify (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Hospitals of Cleveland

Official(s) and/or principal investigator(s):
Robert L Findling, MD, Principal Investigator, Affiliation: University Hospitals of Cleveland

Overall contact:
Nicole Kovach, BA, Phone: 216-844-3922, Email: nicole.kovach@uhhospitals.org

The purpose of this study is to look at the safety and effectiveness of aripiprazole (abilify) in children with bipolar disorder and to examine whether or not patients that respond to initial mood stabilization benefit from continued pharmacotherapy.

Official title: Aripiprazole in Children With Symptoms of Mania

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Primary outcome: YMRS

Detailed description: This outpatient study will be conducted in 3 phases. Phase 1: Patients meeting entry criteria will be treated with open label APZ in order to achieve therapeutic doses of this agent. The primary objective of this phase is to stabilize the patient's mood prior to randomization in phase 2. Adjunctive treatment of attention-deficit hyperactivity disorder (ADHD) will be permitted during this phase after week 6 of phase 1. In order to be entered into Phase 2, patients must be clinically stable based on a priori criteria (see below). The maximum allowable duration of Phase 1 will be 16 weeks. Only patients who have achieved syndromal remission (not just improvement) will be eligible for randomization into phase 2.

Phase 2: Patients that achieve syndromal remission during Phase 1 will be randomized in a double-blind fashion to receive either ongoing APZ therapy or placebo therapy during Phase 2. Patients who are receiving co-administration of ADHD pharmacotherapy may continue with this during Phase 2. Patients will have an equal chance of being assigned to each of the 2 treatment arms. Randomization strata will be based on whether or not the subject is receiving ADHD pharmacotherapy and whether or not the subject is suffering from Bipolar 1 or 2 disorders. The maximum length of time a patient may remain in phase 2 will be 72 weeks. Youths who develop a major depressive episode, a manic, or mixed episode, or youths for whom continued enrollment in this phase of study is contraindicated (as determined by the patient, guardian, research team or study physician), will be withdrawn from phase 2. Youths who withdraw from phase 2 may enter Phase 3. Reason for removal from phase 2 will be documented. For those youths who successfully complete 72 weeks of participation in phase 2, trial participation will be ended. Those patients who complete phase 2 will receive follow up clinical care either at UHC or with a community-based physician.

Phase 3: For youths who are withdrawn during phase 2, 8-weeks of open-label treatment with APZ will be available

Minimum age: 4 Years. Maximum age: 9 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients ages 4-9 years (inclusive)

- Patients who are anticipated to have a Young Mania Rating Scale (Young et al. 1978) of

15 or higher at baseline

- Meet DSM-IV criteria for bipolar disorder type 1 or 2, cyclothymia, or bipolar

disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment (K-SADS-PL supplemented with mood disorder sections from the WASH-U K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist.

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 a documented APZ dose as

monotherapy treatment 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 disorders

- 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 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)

Nicole Kovach, BA, Phone: 216-844-3922, Email: nicole.kovach@uhhospitals.org

University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting
Nicole Kovach, BA, Phone: 216-844-3922, Email: nicole.kovach@uhhospitals.org
Denise Bedoya, MA, Phone: 216-844-4964, Email: denise.delportobedoya@uhhosptials.org
Robert L Findling, MD, Principal Investigator

Starting date: August 2004
Last updated: February 12, 2009