NCT00181831

Completed

Spectroscopy in Children and Adolescents With Bipolar Disord...

Massachusetts General Hospital Source

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Other study identifiers

Sponsor study identifier

2002-P-000661

Study Type

observational

Reported enrollment (type unavailable)

80

Locations

1 country

Sites

1

Timeline

Study Start

December 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2005

Actual (reported)

Study Completion

November 2005

Actual (reported)

Brief Summary

The primary aim of this study is to use proton magnetic resonance spectroscopy to look at myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone. For comparison, results will also be obtained from 20 controls (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior cingular gyrus will be lower in subjects who have received eight weeks or longer of risperidone

Registry Overview

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

Recruitment status: completed
Reported enrollment (type unavailable): 80 participants
Study completion date: November 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

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

Study Start
December 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 16, 2005
Actual (reported)
Primary Completion
November 2005
Actual (reported)
Study Completion
November 2005
Actual (reported)

Last Updated: June 13, 2013
Status Verified: June 2013
Last Update Submitted: June 12, 2013

Conditions

ADHD Bipolar Disorder

Keywords

SPECTbipolar disorderADHDchildren

Interventions

Proton Magnetic Resonance SpectroscopyDevice

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Years - 17 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone.

You may qualify if:

Male or female subjects, 6-17 years of age

Sponsors & Collaborators

Janssen Pharmaceutica
Industrycollaborator
Massachusetts General Hospital
Otherlead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

MeSH Terms

Conditions

Bipolar DisorderAttention Deficit Disorder with Hyperactivity

Interventions

Proton Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Resonance SpectroscopySpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

Joseph Biederman, MD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

December 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2005

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Phase 4Completed

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Phase 1Completed

NCT00181636

Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder

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NCT00181675

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Phase 4Completed

Subject and parent 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 legal representatives must be considered reliable

Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.

Bipolar subjects must have a diagnosis of bipolar I or bipolar II disorder with a lifetime manic or mixed episode (with or without psychotic features) according to the DSM-IV confirmed by structured diagnostic interview (KSADS)

ADHD subjects must meet full criteria for ADHD (with or without hyperactivity) according to the DSM-IV confirmed by structured diagnostic interview (KSADS)

You may not qualify if:

Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
Pregnant of nursing females
Presence of metal or surgical devices (aneurysm clips, metal plates, cochlear implants, neurostimulators, braces, and other items) in vital areas.
Severe phobia of being in small, enclosed spaces (claustrophobic)
Bipolar subjects must either have been free of antipsychotic medication (including risperidone) for 3 months of longer OR be currently treated with risperidone for 8 weeks or longer.
ADHD subjects must not meet criteria for bipolar disorder by structured interview (KSADS). These subjects must be free of antipsychotic medication for 3 months or longer).
Control subjects must not meet criteria for ADHD or bipolar disorder by structured interview (KSADS). These subjects must be free of antipsychotic medication treatment for 3 months or longer.
Left hand dominant subjects will be excluded

Contact the study team to confirm eligibility.

Actual (reported)

Study Completion

November 2005

Actual (reported)

Last Updated

June 13, 2013

Record last verified: 2013-06

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: NCT00181831
Data provider: ClinicalTrials.gov
Source updated: 2013-06-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:15 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations