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

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: Depression

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L4X3
      • Providence Care Mental Health Services

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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.	pre and post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between the change in BDNF levels and illness severity after treatment.	pre and post treatment

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Roumen Milev, MD, FRCP(C), Queen's University

Study record dates

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: Behavioral Symptoms; Depression
• Other Study ID Numbers: PSIY-252-06