DEPRESSIONPhase 2NCT01255072
rTMS in Elderly Depressed:Neuronavegated Study
A Phase 2 study testing Transcranial Magnetic Stimulation and Repetitive Transcranial Magnetic Stimulation in people with DEPRESSION, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This double-blind, controlled and randomized study intents to investigate the antidepressive response of rTMS on the elderly population.This is the first neuronavegated pulse intensity corrected study of rTMS in elderly depressed patients. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- DEPRESSION
- What is being tested?
- Transcranial Magnetic Stimulation and Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Dec 2011
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet criteria for Major Depressive Episode (MDE) (DSM-IV, 1994; SCID-P, 1994);
- Severity of the episode of mild to moderate
- Aged between 60 and 75 years;
- Both genders;
- In case of previous depressive episode, complete remission of the same for at least 6 weeks as measured by the clinical history;
- washed out of psychotropic drugs for one week, including antidepressants; except fluoxetine, which must have three week interval;
- Granting a written informed consent to participate in the study (Annex II)
Who cannot join
- metallic cerebral implants
- history of severe trauma or brain injury
- organic brain disease
- severe somatic disease
- history of other psychiatric diseases
- history of Epilepsy
Show all 15Show fewer
- Non cooperating patients
- Scales and Tests of clinical evaluation:
- Hamilton Depression Rating Scale-17 items
- Geriatric Depression Scale (GDS)
- Mini Mental State Examination
- Clock Drawing Test
- Clinical Dementia Rating
- Visual Analogue Scale
- Clinical Global Impression.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
São Paulo, São Paulo
TMS Department, +5511 3069 8159, emt@hcnet.usp.br
About this study
Official title: Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study
This double-blind, controlled and randomized study intents to investigate the antidepressive response of rTMS on the elderly population.This is the first neuronavegated pulse intensity corrected study of rTMS in elderly depressed patients.
Read the detailed description
Most part of the studies uses samples of severe depressive patients with refractoriness and/or psychotic symptoms, which leave lacuna about the effects on depressive disorder with low or moderate scores. The literature is poor about the use of Repetitive Transcranial Magnetic Stimulation (rTMS) in the old age population.Therefore, we chose this group to research for the antidepressive effect of TMS; other interests are to identify modifications in the magnetic resonance imaging, evaluate cognitive functions and to verify the occurrence of collateral effects and safety use for this specific population.
- Conditions
- DEPRESSION
- Being tested
- Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation
- Keywords
- TMS, elderly, depression, neuronavegation, neurocognition
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationProcedure or surgery
Also called Sham TMS
20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.
Repetitive Transcranial Magnetic StimulationProcedure or surgery
Also called TMS
20 daily sessions: each one with 25 trains of 10seconds at 5Hz, train interval of 25 seconds (time off), pulse intensity corrected based on atrophy degree by a specific correction formule. Target: left dorsolateral prefrontal cortex.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS + placebo | Active comparator | Patients, free from medication for at least one week (washout of 3 weeks for fluoxetine users) will receive 20 sessions of active rTMS delivered to the left Dorsolateral PreFrontal Cortex. Each patient will take placebo pills for 60 day,starting parallel on the first rTMS day. Receives: Procedure: Repetitive Transcranial Magnetic Stimulation |
| SHAM | Sham comparator | Patients, free from medication at least for one week (washout of 3 weeks for fluoxetine users)receiving 20 sessions of Sham TMS delivered to the left dordolateral prefrontal cortex, at the same time this washed out of antidepressives patients start taking Citalopram 20mg/day, for 60 days. Receives: Procedure: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment.
evaluation also by Geriatric Depression Scale (GDS)
Measured: 30 months
Secondary outcomes (1)
Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment.
recruting
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2009
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DEPRESSIONStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bianca B. Bellini, Principal investigator, Department and Institute os Psychiatry, General Hospital, University Of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255072
- Sponsor's protocol ID
- BBellini - 0996/07
- Status last verified
- May 2007
- First submitted
- 3 Dec 2010
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study
- ClinicalTrials.gov ID
- NCT01255072
- Acronym / sponsor ID
- BBellini - 0996/07
- Conditions
- DEPRESSION
- Keywords
- TMS, elderly, depression, neuronavegation, neurocognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 7 Dec 2010 (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.
This double-blind, controlled and randomized study intents to investigate the antidepressive response of rTMS on the elderly population.This is the first neuronavegated pulse intensity corrected study of rTMS in elderly depressed patients.
Detailed description
Most part of the studies uses samples of severe depressive patients with refractoriness and/or psychotic symptoms, which leave lacuna about the effects on depressive disorder with low or moderate scores. The literature is poor about the use of Repetitive Transcranial Magnetic Stimulation (rTMS) in the old age population.Therefore, we chose this group to research for the antidepressive effect of TMS; other interests are to identify modifications in the magnetic resonance imaging, evaluate cognitive functions and to verify the occurrence of collateral effects and safety use for this specific population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS + placebo | Active comparator | Procedure: Repetitive Transcranial Magnetic StimulationPatients, free from medication for at least one week (washout of 3 weeks for fluoxetine users) will receive 20 sessions of active rTMS delivered to the left Dorsolateral PreFrontal Cortex. Each patient will take placebo pills for 60 day,starting parallel on the first rTMS day. |
| SHAM | Sham comparator | Procedure: Transcranial Magnetic StimulationPatients, free from medication at least for one week (washout of 3 weeks for fluoxetine users)receiving 20 sessions of Sham TMS delivered to the left dordolateral prefrontal cortex, at the same time this washed out of antidepressives patients start taking Citalopram 20mg/day, for 60 days. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who meet criteria for Major Depressive Episode (MDE) (DSM-IV, 1994; SCID-P, 1994);
- Severity of the episode of mild to moderate
- Aged between 60 and 75 years;
- Both genders;
- In case of previous depressive episode, complete remission of the same for at least 6 weeks as measured by the clinical history;
Key exclusion criteria (15 listed)
- metallic cerebral implants
- history of severe trauma or brain injury
- organic brain disease
- severe somatic disease
- history of other psychiatric diseases
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: Sham TMS20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex. | Procedure or surgery | SHAM |
| Repetitive Transcranial Magnetic StimulationAlso: TMS20 daily sessions: each one with 25 trains of 10seconds at 5Hz, train interval of 25 seconds (time off), pulse intensity corrected based on atrophy degree by a specific correction formule. Target: left dorsolateral prefrontal cortex. | Procedure or surgery | Active rTMS + placebo |
Primary outcome
Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment.
Time frame: 30 months
evaluation also by Geriatric Depression Scale (GDS)
1 secondary outcome
Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment.
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
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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.
Bianca B. Bellini principal investigator
Department and Institute os Psychiatry, General Hospital, University Of São Paulo
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 Transcranial Magnetic Stimulation and Repetitive Transcranial Magnetic Stimulation in people with DEPRESSION, 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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 30 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bianca B. Bellini (+5511 30698159, bellinibianca@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment. (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2011.