A Randomised Phase ?/? Trial to Explore the Repetitive Transcranial Magnetic Stimulation on the Effects of Hypothalamic-Pituitary-Adrenal Axis of Patients with Depression

• Register: ChiCTR
• Last refreshed on: 28 April 2013
• Main ID: ChiCTR-TRC-09000465
• Date of registration: 2009-07-23
• Primary sponsor: Lianyungang Hospital Affiliated to Medical College of Xuzhou
• Public title: A Randomised Phase ?/? Trial to Explore the Repetitive Transcranial Magnetic Stimulation on the Effects of Hypothalamic-Pituitary-Adrenal Axis of Patients with Depression
• Scientific title: A Double-Blind Randomized Phase ?/? Trial of Daily to Compare Sleep Electroencephalogram-Modulated Repetitive Transcranial Magnetic Stimulation(rTMS) with Conventional rTMS and Sham rTMS for Depressio
• Date of first enrolment: 2007-08-01
• Target sample size: A:57;B:55;C:52;
• Recruitment status: Completed
• URL: http://www.chictr.org/en/proj/show.aspx?proj=934
• Study type: Interventional
• Study design: Randomized parallel control

Countries of recruitment

China

Contacts

• Name: Mingli He

• Name: Mingli He

Key inclusion & exclusion criteria

Inclusion criteria: 1.Age of 12 to 76 years old, male or female;
2.Depression was diagnosed according to the diagnostic criteria of the Diagnostic and Statistical Manual 3th edition (DSM-?);
3.The subjects or their guardian signed a study consent form before enrollment.
Exclusion criteria: 1. Organic mental disorder based on the following criteria: Computed tomography and/or magnetic resonance imaging showed evidence of organic nervous system lesions; nervous system examination revealed organic central nervous system lesions; history of stroke, cerebral hemorrhage, poisoning or other serious central nervous system disease or sequelae of a serious mental disorder caused by organic diseases of other systems;
2. Psychoactive substance- or nonaddictive substance-induced depression;
3. Refusal of medical treatment;
4. Association with other mental illness and strong tendency for suicide;
5. Unable to stop drug treatment because of a physical disease.

Age minimum: 12
Age maximum: 76
Gender: Both

Health Condition(s) or Problem(s) studied

Depression disorder

F32.902

Intervention(s)

A:Sleep electroencephalogram-modulated repetitive transcranial magnetic stimulation;B:Conventional repetitive transcranial magnetic stimulation;C:Sham repetitive transcranial magnetic stimulation;

Primary Outcome(s)

HADM scores;Concentration of ACTH and COR;

Source(s) of Monetary Support

Human Resource Bureau, Science and Technology Department of Jiangsu Province Government

Secondary Sponsor(s)

Human Resource Bureau, Science and Technology Department of Jiangsu Province Government