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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00630123
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the change in brain derived neurotrophic factor (BDNF) between pre and post treatment for patients with depression with either ECT or TMS.

Condition or disease
Depression

Study Design

Study Type : Observational
Actual Enrollment : 36 participants
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.
Study Start Date : November 2006
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. Serum levels of BDNF. [ Time Frame: pre and post treatment ]

Secondary Outcome Measures :
  1. Correlation between the change in BDNF levels and illness severity after treatment. [ Time Frame: pre and post treatment ]

Biospecimen Retention:   Samples Without DNA
serum frozen

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630123


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

Responsible Party: Dr. Roumen Milev, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00630123     History of Changes
Other Study ID Numbers: PSIY-252-06
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015