- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00630123
Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation(TMS) on Brain Derived Neurotrophic Factor (BDNF) in Depressed Patients.
December 14, 2015 updated by: Dr. Roumen Milev, Queen's University
Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) on Serum Levels of Brain Derived Neurotrophic Factor in Depressed Patients.
To investigate the change in brain derived neurotrophic factor (BDNF) between pre and post treatment for patients with depression with either ECT or TMS.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
36
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
-
-
Ontario
-
Kingston, Ontario, Canada, K7L4X3
- Providence Care Mental Health Services
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults patients with current major depressive disorder or bipolar depression who are to receive either ECT or TMS.
Description
Inclusion Criteria:
- MDD or bipolar disorder;
- current depressive episode, ham-d17>17 and ymrs<8;
- recommended to receive ECT or TMS as part of clinical care;
- male/female;
- age 18-65;
- inpatient or outpatient;
- comorbid dysthymic disorder, gad, or social anxiety will be included;
- able to give written consent and agree.
Exclusion Criteria:
- current manic, hypomanic, or mixed episode, ymrs>7;
- current schizophrenia, anorexia, bulimia, substance dependence (current within past 6 months excluding caffeine and nicotine);
- TMS or ECT in the last 3 months;
- any other primary diagnosis;
- uncontrolled medical illness;
- epilepsy or severe personality disorder at the discretion of the investigators;
- 3 weeks prior to first blood test, antidepressants, mood stabilizers, antipsychotics can not be added or increased;
- pregnant women or women of childbearing potential not willing to use appropriate contraception, nursing women;
- known intolerance or lack of response to treatment receiving as judged by the investigator;
- medical conditions that would affect serum levels of BDNF;
- involvement in planning and conduct of the study.
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
Cohorts and Interventions
Group / Cohort |
---|
1
Electroconvulsive Therapy (ECT): blood sample taken from this group at start and after therapy; subjects not randomized to therapy option.
|
2
Transcranial Magnetic Stimulation (TMS): blood sample taken from this group at start and after therapy; subjects not randomized to therapy option.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum levels of BDNF.
Time Frame: pre and post treatment
|
pre and post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between the change in BDNF levels and illness severity after treatment.
Time Frame: pre and post treatment
|
pre and post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roumen Milev, MD, FRCP(C), Queen's University
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 Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 26, 2008
First Submitted That Met QC Criteria
March 5, 2008
First Posted (Estimate)
March 6, 2008
Study Record Updates
Last Update Posted (Estimate)
December 16, 2015
Last Update Submitted That Met QC Criteria
December 14, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSIY-252-06
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.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
-
Lawson Health Research InstituteTerminated