Priming rTMS In Major Depression
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00168272 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : April 16, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Device: Transcranial Magnetic Stimulation | Not Applicable |
The primary outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis. At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of less than or equal to 10.
Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale). A cognitive battery is also administered.
Inclusion Criteria:
- Moderate to severe depressive symptoms as indicated as MADRS >20
- Failure to respond to a minimum of two antidepressant medications
- No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial Exclusion Criteria
- Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
- Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
- In the opinion of the investigator, are a sufficient suicide risk to require immediate electro-convulsive therapy
- Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomised Double-Blind Trial of Low and High Frequency Stimulation rTMS (Repetitive Transcranial Magnetic Stimulation) In Major Depression |
Study Start Date : | June 2004 |
Actual Study Completion Date : | March 2007 |

- The primary outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as less or equal to 10.
- Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Moderate to severe depressive symptoms as indicated as MADRS >20
- Failure to respond to a minimum of two antidepressant medications
- No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial
Exclusion Criteria:
- Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
- Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
- In the opinion of the investigator, are a sufficient suicide risk to require immediate electro-convulsive therapy
- Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168272
Australia, Victoria | |
Alfred Psychiatry Research Centre | |
Melbourne, Victoria, Australia, 3004 |
Principal Investigator: | Paul B Fitzgerald, MBBS, PhD | Alfred Psychiatry Research Centre |
ClinicalTrials.gov Identifier: | NCT00168272 |
Other Study ID Numbers: |
5/04 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | April 16, 2007 |
Last Verified: | April 2007 |
Transcranial Magnetic Stimulation Depression |
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |