Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00806143
Other study ID # TMSDEP
Secondary ID
Status Completed
Phase Phase 4
First received December 8, 2008
Last updated February 23, 2011
Start date September 2008
Est. completion date January 2009

Study information

Verified date February 2011
Source Institute of Neuroscience, Florence, Italy
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal.


Description:

To compare these different procedures we study patients with unipolar recurrent resistant major depressive disorder in a double-blind, controlled trial randomized to either sequential bilaterally on the right and left dorsolateral prefrontal cortex (DLPFC) or monolaterally on the right DLPFC. Patients will be randomized to receive sequentially low-frequency rTMS at 1 Hz to the right DLPFC and high-frequency rTMS at 10 Hz rTMS to the left DLPFC, or to receive low-frequency rTMS at 1 Hz to the right DLPFC. Significant antidepressant effect as expressed by a reduction of Hamilton Depression Scale score will be recorded in both the groups of patients.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnostic and Statistical Manual-IV criteria for Depressive Major Episode Hamilton Rating Scale for Depression -28 (Ham-D)score = 18

- Failure to respond to a minimum of two courses of antidepressant medications for at least 6 weeks

Exclusion Criteria:

- Any comorbid axis I disorder (except simple and social phobia)

- Any other significant medical, particularly neurologic, illnesses (seizures, head trauma and brain lesions)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Device:
repetitive transcranial stimulation (rTMS)
Repetitive TMS will be administered using a MAGSTIM rapid magnetic stimulator (Magstim Company, Ltd., Whitland, U.K.) and a 70-mm figure-eight shaped coils. In monolateral treatment in right DLPFC, three 140-second trains will be applied at 1 Hz and at 110% of RMT. There is a 30 seconds intertrain interval (total of 420 stimuli per session). In sequential treatment, the stimulation will be applied in the first to the right and then to the left dorsolateral prefrontal cortex. In right DLPFC will be applied three 140-second trains at 1 Hz and at 110% of RMT. There will be a 30 seconds intertrain interval (total of 420 stimuli per session). In left DLPFC will be applied twenty 5-second trains were applied at 10 Hz and at 100% of RMT. There will be a 25-second intertrain interval (total of 1000 stimuli per session). Patients will be treated from Monday to Friday, for a total of 15 days.
unilateral stimulation
Patients will be treated from Monday to Friday, for a total of 15 days in the same timeframe of the active group right sided low frequency stimulation

Locations

Country Name City State
Italy Institute of Neuroscience Florence

Sponsors (1)

Lead Sponsor Collaborator
Institute of Neuroscience, Florence, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Depression Scale (HAM-D) at baseline and 3rd week No
Secondary Clinical Global Impression Scale (CGI) baseline and 3rd week No
See also
  Status Clinical Trial Phase
Completed NCT03062150 - Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression N/A
Completed NCT04352101 - Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits Phase 4
Completed NCT02855918 - Blood Biomarkers in Suicidal Behaviour N/A
Recruiting NCT03039387 - Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients N/A
Recruiting NCT02213016 - Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients Phase 4
Completed NCT01636791 - CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care Phase 3
Completed NCT01683539 - Understanding How Cognitive Remediation Works N/A
Recruiting NCT02237937 - Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene Phase 4
Completed NCT01201148 - Open Pilot Trial of TES for Depression Phase 2
Completed NCT00953108 - Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients Phase 3
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Terminated NCT00695552 - The Effect of Exercise on Depressive Symptoms in Unmedicated Patients N/A
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00482482 - Yoga in Unipolar and Bipolar Disorders N/A
Completed NCT00532480 - Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine Phase 4
Completed NCT00466323 - The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness. N/A
Completed NCT00616759 - The Effect on Cognition of Terminating ECT Induced Seizures With Propofol N/A
Recruiting NCT00209807 - Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder Phase 4
Completed NCT00149110 - Chronos: the Use of Chronobiological Treatment in Depression N/A
Completed NCT00167310 - Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation Phase 2

External Links