Clinical trial NCT01452321: Repetitive Transcranial Magnetic Stimulation in Postpartum Depression
Official title: Repetitive Transcranial Magnetic Stimulation Effects on Clinical, Cognitive and Social Performance in Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression, Postpartum
Keywords: Transcranial Magnetic Stimulation;
Postpartum Depression;
Clinical Performance;
Cognitive Performance;
Social Performance
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Battery of Neuropsychological Tests and Social Adjustment Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Martin L Myczkowski, MSD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia KS, Flynn P, Pierce KJ, Caudle M. Repetitive transcranial magnetic stimulation treats postpartum depression. Brain Stimul. 2010 Jan;3(1):36-41. doi: 10.1016/j.brs.2009.06.001. Epub 2009 Jul 8.