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

An observational study of Depression, run by Queen's University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression
How many people: 36 participants
Where: 1 siteCanada
Study dates: Nov 2006to Dec 2012
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adults patients with current major depressive disorder or bipolar depression who are to receive either ECT or TMS.

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Providence Care Mental Health Services
Kingston, Ontario, K7L4X3

Other trials in Canada

About this study

Official title: 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.

Conditions: Depression
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00630123
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

Serum levels of BDNF.
Measured: pre and post treatment

Secondary outcomes (1)

Correlation between the change in BDNF levels and illness severity after treatment.
Measured: pre and post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Dec 2012

First posted6 Mar 2008 (estimated)
Study startNov 2006
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00630123
Sponsor's protocol ID: PSIY-252-06
Status last verified: Dec 2015
First submitted: 26 Feb 2008
Last updated: 16 Dec 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) on Serum Levels of Brain Derived Neurotrophic Factor in Depressed Patients.
ClinicalTrials.gov ID: NCT00630123
Acronym / sponsor ID: PSIY-252-06
Conditions: Depression
Study type: Observational
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Queen's UniversityUniversity, hospital or other
Study start: Nov 2006
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 6 Mar 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults patients with current major depressive disorder or bipolar depression who are to receive either ECT or TMS.

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Serum levels of BDNF.
Time frame: pre and post treatment

1 secondary outcome

Correlation between the change in BDNF levels and illness severity after treatment.
Time frame: pre and post treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.

Related trials for Depression

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roumen Milev, MD, FRCP(C) principal investigator

Queen's University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by Queen's University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum levels of BDNF. (time frame: pre and post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00630123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.