Repetitive Transcranial Magnetic Stimulation in Postpartum Depression (rTMSPPD)

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 2

Conditions: Depression, Postpartum

Treatments: Procedure: repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01452321

0588/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

Sham rTMS

Placebo Comparator group

Description:

Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.

Treatment:

Procedure: repetitive transcranial magnetic stimulation (rTMS)

Active rTMS

Active Comparator group

Description:

Drug-free patients, receiving 20 sessions (1 session daily) of active rTMS delivered to the left dorsolateral prefrontal cortex.

Treatment:

Procedure: repetitive transcranial magnetic stimulation (rTMS)