DepressionPhase 2NCT00220610
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION
A Phase 2 study testing Transcranial magnetic stimulation in people with Depression, run by St. Lucas Andreas Ziekenhuis Hospital at 1 site in Netherlands.
Trial summary
Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2004to Dec 2006
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included
Who cannot join
- A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study.
- Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
st. Lucas Andreas Ziekenhuis/ Hospital
Amsterdam, 1061 AE
Judith van der Riet, Drs, 0031-20-5108562, j.vanderriet@slaz.nl
G.F Koerselman, Prof.dr., 0031-20-5108562, f.koerselman@slaz.nl
About this study
Official title: Right Parietal Inhibition With rTMS in the Treatment of Depression
Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex.
We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales.
We hypothesized that rTMS has a positive effect in the treatment of depression
- Conditions
- Depression
- Being tested
- Transcranial magnetic stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5)
Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)
Secondary outcomes (6)
-Changes in anxiety
-.Autonomic changes
-.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
-.Biochemical changes
-.Changes in the EEG
>> measured before tms and after (at T=0 and T=2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2004
- Study completionDec 2006
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.
- 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
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- St. Lucas Andreas Ziekenhuis Hospital
- Sponsor type
- University, hospital or other
- Investigators
- G.F Koerselman, prof. dr., Study director, st Lucas Andreas Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220610
- Sponsor's protocol ID
- CCMO03.3741/SH/P03.1231L
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Parietal Inhibition With rTMS in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT00220610
- Acronym / sponsor ID
- CCMO03.3741/SH/P03.1231L
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- St. Lucas Andreas Ziekenhuis HospitalUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Dec 2006
- First posted
- 22 Sep 2005 (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.
Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex.
We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales.
We hypothesized that rTMS has a positive effect in the treatment of depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included
Key exclusion criteria (2 listed)
- A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study.
- Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.
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 stimulation | Device | – |
Primary outcome
To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5)
Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)
6 secondary outcomes
-Changes in anxiety
-.Autonomic changes
-.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
-.Biochemical changes
-.Changes in the EEG
>> measured before tms and after (at T=0 and T=2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
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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.
G.F Koerselman, prof. dr. study director
st Lucas Andreas Ziekenhuis
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 in people with Depression, run by St. Lucas Andreas Ziekenhuis Hospital at 1 site in Netherlands.
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 1 inclusion and 2 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 22 Sep 2005. 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 Netherlands. 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. 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 Judith van der Riet, Drs. (0031-20-5108562, j.vanderriet@slaz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5). The study lists 2 primary outcomes in all. 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 22 Sep 2005.