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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Queen's University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Roumen Milev, Queen's University
ClinicalTrials.gov Identifier:
NCT00630123
First received: February 26, 2008
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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
Depression

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


Estimated Enrollment: 36
Study Start Date: November 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Roumen Milev, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00630123     History of Changes
Other Study ID Numbers: PSIY-252-06
Study First Received: February 26, 2008
Last Updated: May 22, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014