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

Condition(s) targeted: ADHD; Bipolar Disorder

Intervention: methylphenidate HCl (Concerta) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Joseph Biederman, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Scores on the Young Mania Rating Scale

CGI-ADHD

ADHD-RS

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.

Minimum age: 6 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Massachusetts General Hospital, Cambridge, Massachusetts 02138, United States

Starting date: August 2002
Ending date: August 2005
Last updated: September 13, 2005