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Repetitive Transcranial Magnetic Stimulation in Postpartum Depression (rTMSPPD)

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ClinicalTrials.gov Identifier: NCT01452321
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : October 14, 2011
Sponsor:
Information provided by (Responsible Party):
Eduardo Moacyr Krieger, 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.


Condition or disease Intervention/treatment Phase
Depression, Postpartum Procedure: repetitive transcranial magnetic stimulation (rTMS) Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation Effects on Clinical, Cognitive and Social Performance in Postpartum Depression
Study Start Date : August 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2009

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U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Sham rTMS
Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
Procedure: repetitive 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

Other Name: TMS
Active Comparator: Active rTMS
Drug-free patients, receiving 20 sessions (1 session daily) of active rTMS delivered to the left dorsolateral prefrontal cortex.
Procedure: repetitive 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

Other Name: TMS



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452321


Locations
Brazil
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Martin L Myczkowski, MSD University of Sao Paulo General Hospital

Publications:
Responsible Party: Eduardo Moacyr Krieger, Associate Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01452321     History of Changes
Other Study ID Numbers: 0588/07
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: October 14, 2011
Last Verified: October 2011

Keywords provided by Eduardo Moacyr Krieger, University of Sao Paulo General Hospital:
Transcranial Magnetic Stimulation;
Postpartum Depression;
Clinical Performance;
Cognitive Performance;
Social Performance

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications