NCT00181987

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

October 21, 2013

Conditions

ADHDBipolar Disorder

Keywords

ADHDbipolar disorderchildrenConcerta

Outcome Measures

Primary Outcomes (3)

  • Scores on the Young Mania Rating Scale

  • CGI-ADHD

  • ADHD-RS

Interventions

methylphenidate HCl (Concerta)DRUG

Eligibility Criteria

Age6 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female subjects, 5-55 years of age.
  • 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.
  • 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.
  • 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.
  • Subject must be able to participate in mandatory blood draws.
  • Subject must be able to swallow pills.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityBipolar Disorder

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joseph Biederman, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 1, 2002

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

US(1)