Text Size

Repetitive Transcranial Magnetic Stimulation in Postpartum Depression (rTMSPPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eduardo Moacyr Krieger, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01452321
First received: November 22, 2010
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Depression, Postpartum
 Procedure: repetitive transcranial magnetic stimulation (rTMS)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation Effects on Clinical, Cognitive and Social Performance in Postpartum Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Battery of Neuropsychological Tests and Social Adjustment Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 14
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 36 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: November 22, 2010
Last Updated: October 10, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013