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Repetitive Transcranial Magnetic Stimulation in Postpartum Depression (rTMSPPD)

Primary Purpose

Depression, Postpartum

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

repetitive transcranial magnetic stimulation (rTMS)

About this trial

This is an interventional treatment trial for Depression, Postpartum focused on measuring Transcranial Magnetic Stimulation;, Postpartum Depression;, Clinical Performance;, Cognitive Performance;, Social Performance

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham rTMS

Active rTMS

Arm Description

Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.

Drug-free patients, receiving 20 sessions (1 session daily) of active rTMS delivered to the left dorsolateral prefrontal cortex.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Battery of Neuropsychological Tests and Social Adjustment Scale

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)

Full Information

NCT ID

NCT01452321

First Posted

November 22, 2010

Last Updated

October 10, 2011

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01452321

Brief Title

Repetitive Transcranial Magnetic Stimulation in Postpartum Depression

Acronym

rTMSPPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Postpartum

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sham rTMS

Arm Type

Placebo Comparator

Arm Description

Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.

Arm Title

Active rTMS

Arm Type

Active Comparator

Arm Description

Drug-free patients, receiving 20 sessions (1 session daily) of active rTMS delivered to the left dorsolateral prefrontal cortex.

Intervention Type

Procedure

Intervention Name(s)

repetitive transcranial magnetic stimulation (rTMS)

Other Intervention Name(s)

TMS

Intervention Description

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

Primary Outcome Measure Information:

Title

Hamilton Depression Rating Scale (HDRS)

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Battery of Neuropsychological Tests and Social Adjustment Scale

Description

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

36 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin L Myczkowski, MSD

Organizational Affiliation

University of Sao Paulo General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

20633429

Citation

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.

Results Reference

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Repetitive Transcranial Magnetic Stimulation in Postpartum Depression

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