Status:
COMPLETED
Deep-brain Magnetic Stimulation (DMS) in the Treatment of Major Depressive Disorder
Lead Sponsor:
Capital Medical University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in major depressive disorder, but the effectiveness is not clear due to stimulated region, frequency and intensi...
Detailed Description
The study is designed as randomized, double-blinded, active-controlled trial in major depressive disorder. Patients will be male or female, 18 to 60 years of age, right-handed, outpatient or inpatien...
Eligibility Criteria
Inclusion
- Has given written informed consent.
- Aged from 18 to 60 years old.
- Has a diagnosis of major depressive disorder by DSM-IV criteria.
- HAMD-17 ≥ 18.
- Right-handed.
- Be drug free at least 30 days at randomization.
Exclusion
- Current Axis I primary psychiatric diagnosis other than major depressive disorder.
- Organic mental disease, including mental retardation.
- History of clinically significant disease, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require treatment during the study.
- Subjects receiving an investigational agent (including different formulation and generic agents of investigational drug) in the previous 3 months prior to screening.
- Women in pregnancy or lactation, or female of child bearing potential without appropriate birth control measures.
- Has received ECT or MECT within 3 months prior to screening.
- Significant risk of suicidal and/or self-harm behaviors.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02184221
Start Date
May 1 2010
End Date
April 1 2011
Last Update
August 31 2017
Active Locations (1)
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1
Beijing Anding Hospital
Beijing, Beijing Municipality, China, 100088