Repetitive Transcranial Magnetic Stimulation in Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of postpartum depression. However, up to current days there have been no studies evaluating the effects of rTMS on neurocognitive and social performance of women suffering from the disorder. The present study evaluates the impacts of rTMS in clinical, cognitive and social performance.

Detailed Description
-----------------
Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects. The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. Each session lasts up to 30 minutes. Side effects include scalp discomfort and mild headache. No anesthesia is required. Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. The present technique has never been employed in previous studies, but risks are insignificant.

Official Title
-----------------
Repetitive Transcranial Magnetic Stimulation Effects on Clinical, Cognitive and Social Performance in Postpartum Depression

Conditions
-----------------
Depression, Postpartum

Intervention / Treatment
-----------------
* Procedure: repetitive transcranial magnetic stimulation (rTMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major depression with a puerperal onset, according to the criteria of the DSM-IV-R (APA, 2000), as well as through a structured clinical interview (SCID-1/P v 2.0) baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items baseline score of at least 13 points on the Edinburgh Postnatal Depression Scale. range = 18-36 years women who had given birth 1-6 months any pharmacological treatment other than clonazepam (1 mg/day) Exclusion Criteria: comprised ferromagnetic metallic implants pacemakers previous neurosurgery history of seizures major head trauma alcoholism drug addiction any psychiatric or neurological disorder other than depression and anxiety psychotic depression suicidal propensities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham rTMS<br>Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex. | Procedure: repetitive transcranial magnetic stimulation (rTMS)<br>* 20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold. Site: Left Dorsolateral Prefrontal Cortex<br>* Other names: TMS;|
| Active Comparator: Active rTMS<br>Drug-free patients, receiving 20 sessions (1 session daily) of active rTMS delivered to the left dorsolateral prefrontal cortex. | Procedure: repetitive transcranial magnetic stimulation (rTMS)<br>* 20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold. Site: Left Dorsolateral Prefrontal Cortex<br>* Other names: TMS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS) | Reduction on the scores of HDRS (as on the scores of Edinburgh Pospartum Depression Scale and Hamilton Anxiety Scale; and improves the global clinical status in Clinical Global Impression, Global Assessment Scale and 36-item Short-form Health Survey - Quality of Life) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Battery of Neuropsychological Tests and Social Adjustment Scale | Performance of neuropsychological tests and social function - Trail Making Test, Wisconsin Card Sorting Test, Controlled Oral Word Association Test, Victoria Stroop Test, Rey Auditory Verbal Learning Test, WAIS-III (adapted for use in Brazil) subtests Similarities, Picture Completion, Digit Span, Digit-Symbol Coding and Social Adjustment Scale-Self Report (SAS-SR; adapted for use in Brazil) | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Magnetic Stimulation;, Postpartum Depression;, Clinical Performance;, Cognitive Performance;, Social Performance