Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation(TMS) on Brain Derived Neurotrophic Factor (BDNF) in Depressed Patients.
This study is ongoing, but not recruiting participants.
Sponsor:
Queen's University
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
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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:
MedlinePlus related topics:
Depression
Drug Information available for:
Neurotrophin-3
U.S. FDA Resources
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
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 Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013