Repetitive Transcranial Magnetic Stimulation in Postpartum Depression

Depression, Postpartum Clinical Trial

— rTMSPPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452321
• Other study ID #: 0588/07
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2010
• Last updated: October 10, 2011
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: October 2011
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Brazil	Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	6 weeks	Yes