NCT00592267

Unknown

Screening Protocol for Children and Adolescents With Bipolar...

Massachusetts General Hospital Source

Compare

Other study identifiers

Sponsor study identifier

2001-P-001247

Study Type

observational

Estimated enrollment

1,000

Locations

1 country

Sites

1

Timeline

Study Start

September 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 1,000 participants
Study completion date: December 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2001
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 28, 2007
Actual (reported)
First Posted
January 14, 2008
Actual (reported)
Primary Completion
December 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 18, 2022
Status Verified: January 2022
Last Update Submitted: January 14, 2022

Conditions

Pediatric Bipolar Disorder

Keywords

pediatricbipolar disorder

Outcome Measures

Primary Outcomes (1)

Screening Protocol
This protocol is a prescreening for other research studies.
Study Enrollment

Study Arms (1)

1

Eligibility Criteria

Age4 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

Children and Adolescents with symptoms of bipolar disorder

You may qualify if:

Males and females age 4 to 17 inclusive with a suspected diagnosis of bipolar disorder.

Sponsors & Collaborators

Massachusetts General Hospital
Otherlead

Study Sites (1)

Masschusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

Joseph Biederman, MD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Wolenski

CONTACT

617-643-6617 rwolenski@partners.org

Alexa Pulli, BS

CONTACT

617-726-4651

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 14, 2008

Study Start

September 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

NCT01954680

Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study

Phase 1Unknown

NCT00586222

Omega 3 Fatty Acid Trial

Phase 1Completed

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.

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
Mental retardation

Contact the study team to confirm eligibility.

apulli@mgh.harvard.edu

December 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 18, 2022

Record last verified: 2022-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00592267
Data provider: ClinicalTrials.gov
Source updated: 2022-01-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:08 UTC

Locations

US(1)

Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

1

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

1

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations