Depression, Postpartum
Conditions
Keywords
Transcranial Magnetic Stimulation;, Postpartum Depression;, Clinical Performance;, Cognitive Performance;, Social Performance
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.
Interventions
PROCEDURErepetitive transcranial magnetic stimulation (rTMS)
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
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | 6 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Battery of Neuropsychological Tests and Social Adjustment Scale | 6 weeks | 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) |
Countries
Brazil
Outcome results
None listed