Accelerated Repetitive Transcranial Magnetic Stimulation in the Treatment Of Depressio
- Conditions
- Treatment Resistant Major DepressionMental HealthMajor Depressive DisorderMental Health - Depression
- Registration Number
- ACTRN12613000044729
- Lead Sponsor
- Professor Paul Fitzgerald
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 119
Patients will be included if they:
1. Have a DSM-IV diagnosis of a Major Depressive Episode
2. Have treatment resistant depression at Stage II of the Thase and Rush Classification
3. Have a Hamilton Depression Rating Scale of >20 (moderate-severe depresssion).
4. Have had no increase in, or initiation of new antidepressant (or other psychoactive) therapy in the four weeks prior to screening.
1. Patients who have an unstable medical condition(s), neurological disorder or any history of a seizure disorder or are currently pregnant or lactating or are professional drivers.
2. Have a current DSM-IV diagnosis of Substance Abuse or Dependence disorder, a diagnosis of a personality disorder (SCID II), or another Axis 1 disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in severity of depressive symptoms, defined as: Hamilton Depression Rating Scale (HAMD; 17 item version) - Clinical response defined as a reduction of at least 50% from baseline, clinical remission defined as a score <8. [Week 4, after completion of treatment. ]
- Secondary Outcome Measures
Name Time Method Change in severity of depressive symptoms as shown by score on the Montgomery Asperg Depression Rating Scale (MADRS). [Week 4, after completion of treatment ];Change in severity of depressive symptoms as shown by score on the Beck Depression Inventory (BDI)[Week 4, after completion of treatment ];Score on Scale of Suicidal Ideation (SSI)[Week 4]