Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT00592267

Conditions

Pediatric Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The objective of this protocol is to establish a comprehensive screening process for the evaluation of eligibility for entry in a clinical trial program for children and adolescents with bipolar disorder.

Conditions

Pediatric Bipolar Disorder

Study ID

NCT00592267

Start date

Sep, 2001

Status verified date

Jan, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and females age 4 to 17 inclusive with a suspected diagnosis of bipolar disorder.
  • Subject and parent/ legal guardian 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.
  • Subjects and their parent/ legal representative must be considered reliable.
  • Each subject and his/her parent or authorized legal representative must understand the nature of the study. The subject's parent or authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
  • One parent/ legal guardian must be able to accompany the subject to the clinic at each visit.

Exclusion Criteria:

  • 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
  • Mental retardation

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Primary outcome measure

  • Screening Protocol [ Time Frame: Study Enrollment ]

Central Contacts and Locations

Central contacts

Rebecca Wolenski

617-643-6617rwolenski@partners.org

Alexa Pulli, BS

617-726-4651apulli@mgh.harvard.edu

Locations

Masschusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 18, 2022

Last verified

Jan, 2022

Keywords

  • pediatric
  • bipolar disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-01-18.