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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00592267
Other study ID # 2001-P-001247
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2001
Est. completion date December 2023

Study information

Verified date January 2022
Source Massachusetts General Hospital
Contact Rebecca Wolenski
Phone 617-643-6617
Email rwolenski@partners.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

To address the urgent therapeutic needs of children and adolescents ages 4-17 with pediatric bipolar disorder, we have designed a series of clinical trials aimed at evaluating critical components of the treatment needs of this under-served and under-researched population. This approach will allow us to provide a full complement of clinical trials that will meet the most pressing needs of the bipolar children and adolescents and their families who are currently awaiting treatment. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs makes it very difficult to ask subjects to sign a specific clinical protocol without obtaining additional clinical information. Because of this we are proposing potential subjects to consent to undergo an in-depth clinical assessment that will allow subjects to be screened by a clinician for eligibility to a diverse clinical trials program available to them.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States Masschusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Screening Protocol This protocol is a prescreening for other research studies. Study Enrollment
See also
  Status Clinical Trial Phase
Terminated NCT00592358 - Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder Phase 4
Completed NCT00586222 - Omega 3 Fatty Acid Trial Phase 1
Terminated NCT00592683 - Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents Phase 4
Terminated NCT00592852 - Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder Phase 4
Recruiting NCT01954680 - Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study Phase 1

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