Repetitive Transcranial Magnetic Stimulation in Postpartum Depression

Phase 2

Completed

• Conditions: Depression, Postpartum
• Interventions: Procedure: repetitive transcranial magnetic stimulation (rTMS)

• Registration Number: NCT01452321
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-07
• Study Completion: 2009-09
• Study First Submitted: 2010-11-22
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-10
• Last Update Submitted: 2011-10-10
• Study First Posted: 2011-10-14
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS	repetitive transcranial magnetic stimulation (rTMS)	Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
Active rTMS	repetitive transcranial magnetic stimulation (rTMS)	Drug-free patients, receiving 20 sessions (1 session daily) of active rTMS delivered to the left dorsolateral prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school; 🇧🇷 São Paulo, Brazil