Effect of Electroconvulsive Therapy (ECT) and Transcrania... | NCT00630123

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

NCT00630123

Sponsor

Queen's University

Status

Completed

Last Update Posted

Dec 16, 2015Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Depression

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Mar 5, 2008

First Posted Date

Mar 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2015

Last Update Posted Date

Dec 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
Serum levels of BDNF.		pre and post treatment

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

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior