Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181987
First received: September 13, 2005
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

The objective of this study is to investigate the safety and effectiveness of Concerta in the treatment of children (ages 5 to 17 years old) and adults (ages 18 to 55 years old) with Bipolar I, Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks. This study seeks to study the short-term effectiveness of a long acting formulation of methylphenidate (Concerta) in the treatment of children and adults with bipolar disorder and comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents.


Condition Intervention Phase
ADHD
Bipolar Disorder
Drug: methylphenidate HCl (Concerta)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study of Concerta in the Treatment of ADHD in Youth and Adults With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Scores on the Young Mania Rating Scale
  • CGI-ADHD
  • ADHD-RS

Enrollment: 29
Study Start Date: August 2002
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

A leading source of difficulty in treating youth with Bipolar Disorder is its comorbidity with attention deficit hyperactivity disorder (ADHD). Systematic studies of children and adolescents show that rates of ADHD range from 60% to 90% in pediatric study participants with mania. These findings could not be accounted for by the overlapping symptoms of distractibility, talkativeness, and physical hyperactivity, suggesting that affected children may suffer from both disorders, which was also consistent with findings of familial co-transmission of these two conditions. Considering the well-documented morbidity and dysfunction associated with ADHD, a comprehensive treatment approach to the management of the bipolar child with comorbid ADHD requires the development of appropriate therapeutic strategies for the treatment ADHD symptoms.

The objective of this study is to investigate the safety and effectiveness of Concerta in the treatment of children (ages 5 to 17 years old) and adults (ages 18 to 55 years old) with Bipolar I, Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks. This study seeks to study the short-term effectiveness of a long acting formulation of methylphenidate (Concerta) in the treatment of children and adults with bipolar disorder and comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents.

  Eligibility

Ages Eligible for Study:   6 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects, 5-55 years of age.
  2. Each subject, as well as the legal representative for children under the age of 18, must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
  3. Each subject (and his/her authorized legal representative, if applicable) must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the study participant must sign an informed assent document.
  4. Subjects must have a diagnosis of Bipolar I, Bipolar II, Bipolar NOS or sub-threshold Bipolar Disorder with a stable Young Mania Scale rating of < 15 for at least one month, a Depression CGI-Severity score < 3 (mildly ill), a score on the Hamilton Depression Rating Scale below 15 (mild range), and a comorbid diagnosis of ADHD according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kiddie Schedule of Affective Disorders or Structured Clinical Interview DSM-IV), subjects may not have expressed symptoms for past 20 years.
  5. Subject must be able to participate in mandatory blood draws.
  6. Subject must be able to swallow pills.

Exclusion Criteria:

  1. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  2. Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
  3. Uncorrected hypothyroidism or hyperthyroidism.
  4. History of severe allergies or multiple adverse drug reactions.
  5. Non-febrile seizures without a clear and resolved etiology.
  6. Leukopenia or history of leukopenia without a clear and resolved etiology.
  7. Judged clinically to be at serious suicidal risk.
  8. Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol
  9. History of intolerance or non-responder to Concerta as determined by the principal investigator.

Treatment with nonreversible monoamine oxidase inhibitor within 2 weeks prior to initiation of study.

Current diagnosis of schizophrenia. 12. Diagnosis of any chronic motor or vocal tic, or Tourette's Syndrome.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181987

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181987     History of Changes
Other Study ID Numbers: 2002-P-001148
Study First Received: September 13, 2005
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
ADHD
bipolar disorder
children
Concerta

Additional relevant MeSH terms:
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014