Major DepressionNCT00149071
Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression
A study testing rTMS and TMS in people with Major Depression, run by Hillerod Hospital, Denmark at 1 site in Denmark.
Trial summary
A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram in patients with prior treatment resistant depression in an acute 12 weeks trial with subsequent 24 weeks study phase with active versus placebo citalopram Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depression
- What is being tested?
- rTMS and TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2004to Jan 2006
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depression Hamilton score above 18
- Age 18 to 75
Who cannot join
- Pregnancy og breastfeeding
- Mental retardation and organic brain disease
- Alcohol and substance abuse
- Metal implants in brain, pacemakers and other electronic implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Therapy-Resistant Major Depression With Transcranial Stimulation rTMS in Combination With Escitalopram
A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram in patients with prior treatment resistant depression in an acute 12 weeks trial with subsequent 24 weeks study phase with active versus placebo citalopram
Read the detailed description
In this study we aimed at investigating to what degree rTMS applied over the left dorsolateral cortex relieves depressive symptoms when the treament is combined with antidepressive medication. The study will also be able to supply knowledge on how long any possible effect of the rTMS treatment lasts.
In the first 12 weeks of the trial participants are randomised to either rTMS combined with escitalopram or sham rTMS combined with escitalopram. rTMS is given daily for the first 3 weeks.
The next phase is a relapse prevention study where the responders from the initial phase are randomised to either active or placebo escitalopram for 24 weeks.
- Conditions
- Major Depression
- Being tested
- rTMS, TMS
- Keywords
- Transcranial magnetic stimulation (TMS), Major depression, treatment resistant major depression
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
15 treatments of rTMS active with a duration of 30 minutes each
TMSDevice
Transcraniel Magnetic Stimulation active and sham
rTMSDevice
active Transcranial Magnetic Stimulation
rTMSDevice
daily for three weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | rTMS Receives: Device: rTMS; Device: TMS |
| B | Sham comparator | sham rTMS Receives: Device: TMS; Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression scores
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 posted8 Sep 2005 (estimated)
- Study startMar 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Medicon Valley Academy
- Investigators
- Line G Bretlau, MD, Principal investigator, Psychiatric research Unit, Hilleroed Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149071
- Sponsor's protocol ID
- 1,2
- Status last verified
- Nov 2007
- First submitted
- 6 Sep 2005
- Last updated
- 5 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Therapy-Resistant Major Depression With Transcranial Stimulation rTMS in Combination With Escitalopram
- ClinicalTrials.gov ID
- NCT00149071
- Acronym / sponsor ID
- 1,2
- Conditions
- Major Depression
- Keywords
- Transcranial magnetic stimulation (TMS), Major depression, treatment resistant major depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Collaborators
- Medicon Valley Academy
- Study start
- Mar 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 8 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.
A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram in patients with prior treatment resistant depression in an acute 12 weeks trial with subsequent 24 weeks study phase with active versus placebo citalopram
Detailed description
In this study we aimed at investigating to what degree rTMS applied over the left dorsolateral cortex relieves depressive symptoms when the treament is combined with antidepressive medication. The study will also be able to supply knowledge on how long any possible effect of the rTMS treatment lasts.
In the first 12 weeks of the trial participants are randomised to either rTMS combined with escitalopram or sham rTMS combined with escitalopram. rTMS is given daily for the first 3 weeks.
The next phase is a relapse prevention study where the responders from the initial phase are randomised to either active or placebo escitalopram for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: rTMS, Device: TMSrTMS |
| B | Sham comparator | Device: TMS, Device: rTMSsham rTMS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major depression Hamilton score above 18
- Age 18 to 75
Key exclusion criteria (4 listed)
- Pregnancy og breastfeeding
- Mental retardation and organic brain disease
- Alcohol and substance abuse
- Metal implants in brain, pacemakers and other electronic implants
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 |
|---|---|---|
| rTMS15 treatments of rTMS active with a duration of 30 minutes each | Device | A |
| TMSTranscraniel Magnetic Stimulation active and sham | Device | A, B |
| rTMSactive Transcranial Magnetic Stimulation | Device | A, B |
| rTMSdaily for three weeks | Device | A, B |
Primary outcome
depression scores
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 5 Nov 2007.
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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.
Line G Bretlau, MD principal investigator
Psychiatric research Unit, Hilleroed Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and TMS in people with Major Depression, run by Hillerod Hospital, Denmark at 1 site in Denmark.
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 2 inclusion and 4 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 5 Nov 2007. 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 Denmark. 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.
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?
depression scores (time frame: 6 weeks). 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 5 Nov 2007.