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Completed

NCT Number: NCT01452321

Repetitive Transcranial Magnetic Stimulation in Postpartum Depression

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.

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Key information

Conditions

Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Procedure

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

Other names: TMS

Primary outcomes

  1. Hamilton Depression Rating Scale (HDRS)

    Time frame: 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 outcomes

  1. Battery of Neuropsychological Tests and Social Adjustment Scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Acronym: rTMSPPD

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Oct 14, 2011
Registry last updated
Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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