NCT01452321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
Last Updated

October 14, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

November 22, 2010

Last Update Submit

October 10, 2011

Conditions

Depression, Postpartum

Keywords

Transcranial Magnetic Stimulation;Postpartum Depression;Clinical Performance;Cognitive Performance;Social Performance

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale (HDRS)

    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)

    6 weeks

Secondary Outcomes (1)

  • Battery of Neuropsychological Tests and Social Adjustment Scale

    6 weeks

Study Arms (2)

Sham rTMS

PLACEBO COMPARATOR

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)

Active rTMS

ACTIVE COMPARATOR

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)

Interventions

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

Also known as: TMS
Active rTMSSham rTMS

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Garcia KS, Flynn P, Pierce KJ, Caudle M. Repetitive transcranial magnetic stimulation treats postpartum depression. Brain Stimul. 2010 Jan;3(1):36-41. doi: 10.1016/j.brs.2009.06.001. Epub 2009 Jul 8.

    PMID: 20633429BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Martin L Myczkowski, MSD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 22, 2010

First Posted

October 14, 2011

Study Start

August 1, 2007

Primary Completion

July 1, 2008

Study Completion

September 1, 2009

Last Updated

October 14, 2011

Record last verified: 2011-10

Locations

BR(1)