Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
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| ClinicalTrials.gov Identifier: NCT00194077 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : December 5, 2013
Last Update Posted : January 7, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Aripiprazole Drug: Placebo | Phase 3 |
This outpatient study will be conducted in 3 phases. Phase 1: Patients meeting entry criteria will be treated with open label aripiprazole (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phase of study is contraindicated (as determined by the patient, guardian, research team or study physician), will be withdrawn from phase 2.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 University Hospitals-Cleveland (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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Aripiprazole in Children With Symptoms of Mania |
| Study Start Date : | August 2004 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Aripiprazole
Phase I and Phase III are open label Abilify phases where all subjects receive active Abilify
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Drug: Aripiprazole
dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy
Other Name: Abilify |
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Placebo Comparator: Placebo
in Phase 2 subjects are randomized to either placebo or abilify for up to 72 weeks
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Drug: Placebo
subjects in phase 2 will be randomized to active abilify or placebo |
- Time in Weeks to Discontinuation [ Time Frame: up to 72 weeks ]Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 4 Years to 9 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194077
| United States, Ohio | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| Principal Investigator: | Robert L Findling, MD | Johns Hopkins University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Robert L Findling, MD, Director, Division of Child and Adolescent Psychiatry, University Hospitals Cleveland Medical Center |
| ClinicalTrials.gov Identifier: | NCT00194077 |
| Other Study ID Numbers: |
Children with Mania |
| First Posted: | September 19, 2005 Key Record Dates |
| Results First Posted: | December 5, 2013 |
| Last Update Posted: | January 7, 2015 |
| Last Verified: | December 2014 |
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Bipolar Disorder Bipolar and Related Disorders Mental Disorders Aripiprazole Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Dopamine Agonists |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Dopamine D2 Receptor Antagonists Dopamine Antagonists |