Depression, PostpartumPhase 2rTMSPPDNCT01452321
Repetitive Transcranial Magnetic Stimulation in Postpartum Depression
A Phase 2 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Depression, Postpartum, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- comprised ferromagnetic metallic implants
- pacemakers
- previous neurosurgery
- history of seizures
- major head trauma
- alcoholism
Show all 10Show fewer
- drug addiction
- any psychiatric or neurological disorder other than depression and anxiety
- psychotic depression
- suicidal propensities
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
São Paulo, São Paulo
About this study
Official title: Repetitive Transcranial Magnetic Stimulation Effects on Clinical, Cognitive and Social Performance in Postpartum Depression
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.
Read the 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.
- Conditions
- Depression, Postpartum
- Being tested
- repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Transcranial Magnetic Stimulation;, Postpartum Depression;, Clinical Performance;, Cognitive Performance;, Social Performance
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Procedure or surgery
Also called TMS
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
| Study group | Role | What they receive |
|---|---|---|
| Sham rTMS | Placebo comparator | Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex. Receives: 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. Receives: Procedure: repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
Secondary outcomes (1)
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Moacyr Krieger, University of Sao Paulo General Hospital
- Investigators
- Martin L Myczkowski, MSD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452321
- Sponsor's protocol ID
- 0588/07
- Acronym
- rTMSPPD
- Status last verified
- Oct 2011
- First submitted
- 22 Nov 2010
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20633429
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Effects on Clinical, Cognitive and Social Performance in Postpartum Depression
- ClinicalTrials.gov ID
- NCT01452321
- Acronym / sponsor ID
- rTMSPPD / 0588/07
- Conditions
- Depression, Postpartum
- Keywords
- Transcranial Magnetic Stimulation;, Postpartum Depression;, Clinical Performance;, Cognitive Performance;, Social Performance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham rTMS | Placebo comparator | Procedure: repetitive transcranial magnetic stimulation (rTMS)Drug-free patients, receiving 20 sessions (1 session daily) of sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex. |
| Active rTMS | Active comparator | Procedure: repetitive transcranial magnetic stimulation (rTMS)Drug-free patients, receiving 20 sessions (1 session daily) of active rTMS delivered to the left dorsolateral prefrontal cortex. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- comprised ferromagnetic metallic implants
- pacemakers
- previous neurosurgery
- history of seizures
- major head trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)Also: TMS20 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 | Procedure or surgery | Active rTMS, Sham rTMS |
Primary outcome
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)
1 secondary outcome
Battery of Neuropsychological Tests and Social Adjustment Scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2011.
- Background: PubMed 20633429Garcia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin L Myczkowski, MSD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Depression, Postpartum, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HDRS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2011.