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Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation(TMS) on Brain Derived Neurotrophic Factor (BDNF) in Depressed Patients.

This study has been completed.
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University Identifier:
First received: February 26, 2008
Last updated: December 14, 2015
Last verified: December 2015
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) on Serum Levels of Brain Derived Neurotrophic Factor in Depressed Patients.

Resource links provided by NLM:

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Serum levels of BDNF. [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between the change in BDNF levels and illness severity after treatment. [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
serum frozen

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Electroconvulsive Therapy (ECT): blood sample taken from this group at start and after therapy; subjects not randomized to therapy option.
Transcranial Magnetic Stimulation (TMS): blood sample taken from this group at start and after therapy; subjects not randomized to therapy option.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
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Please refer to this study by its identifier: NCT00630123

Canada, Ontario
Providence Care Mental Health Services
Kingston, Ontario, Canada, K7L4X3
Sponsors and Collaborators
Queen's University
Principal Investigator: Roumen Milev, MD, FRCP(C) Queen's University
  More Information

Responsible Party: Dr. Roumen Milev, Principal Investigator, Queen's University Identifier: NCT00630123     History of Changes
Other Study ID Numbers: PSIY-252-06 
Study First Received: February 26, 2008
Last Updated: December 14, 2015
Health Authority: Canada: Health Canada processed this record on October 25, 2016