- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005116
Depression In Juvenile Diabetics
March 1, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Depression is one of the most common emotional problems among youths with insulin dependent diabetes mellitus (IDDM).
It has been shown that depression in youths with IDDM lasts a while and may have a role in later complications of the medical condition.
And yet, there are no psychological interventions appropriate for such youngsters.
The purpose of this study is to modify a treatment called ''Contextual Psychotherapy'' (that has been developed for depressed youngsters) in order to address special needs of depressed youths with IDDM, and to ''pilot test'' the treatment.
The youngsters to be recruited are those being cared for at the Diabetes Clinic of the Children's Hospital of Pittsburgh.
The treatment includes a 3- month phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later follow-up evaluations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- WPIC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IDDM duration of less than 10 years
- No major medical disorder other than IDDM
- No psychotropic medications
- Meets psychiatric diagnostic criteria for depression
- Parent and child willing to participate
Exclusion Criteria:
- Does not live withing commuting distance
- Mental retardation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dr. Maria Kovacs, U. Of Pittsburgh School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 13, 2000
First Submitted That Met QC Criteria
April 13, 2000
First Posted (Estimate)
April 14, 2000
Study Record Updates
Last Update Posted (Estimate)
March 2, 2010
Last Update Submitted That Met QC Criteria
March 1, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KOVACSM (completed)
- R01DK025568 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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