Major Depressive DisorderNCT00232700
Investigation of a Combination Treatment of Escitalopram and rTMS
A study testing Escitalopram in people with Major Depressive Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Dec 2008
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depressive Episode (according to DSM IV standards)
- HAMD > 20
- Patient has an IQ > 70 based on the investigator´s judgement
- Patient is male or nonpregnant female adequately protected from conception
- Patient is able to comply with all testing and follow-up visit requirements defined by the study protocol
- Patient has voluntarily signed an informed consent in accordance with institutional policies
Who cannot join
- Patient has a history of schizophrenia, schizoaffective disorder or delusional disorder
- Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnestic or other cognitive disorder per DSM IV
- Patient is suicidal
- Patient has had an alcohol or substance dependence within the previous 12 month
- Patient is currently enrolled in another investigational study
- Patient has a history of, or evidence of, significant central nervous disease (especially seizures)
- Patient has previously been treated with escitalopram
- Contraindication against escitalopram or rTMS
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 14050
About this study
Official title: Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation
We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale
Read the detailed description
We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale compared to placebo.
A second hypothesis is that the treatment of MDE with escitalopram (that means in the "Placebo group") alone lead to typical changes like
- An increase in neurotrophic factors concentration (measured by blood concentrations of nerve growth factor (NGF) and brain derived nerve growth factor (BDNF),
- An increase in hippocampal metabolites (measured with magnetic resonance spectroscopy (MRS
- An increase in motor cortical inhibitory activity (measured with motor evoked potentials (MEP
- An increase in serotonergic activity (measured with EEG parameters, Moreover, it is hypothesized that similar but pronounced changes occur in the group treated with the combination treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram
- Keywords
- Major depressive disorder, Repetitive transcranial magnetic stimulation
- 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.
EscitalopramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
Secondary outcomes (4)
To determine the changes of hippocampal metabolites measured by MRS
To assess the changes of parameters of motor cortical inhibition measured by MEP
To assess the changes of NGF and BDNF
To determine the changes of event related potentials measured by electroencephalography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Investigators
- Malek Bajbouj, MD, Principal investigator, Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232700
- Sponsor's protocol ID
- 20050041
- Status last verified
- Sep 2007
- First submitted
- 4 Oct 2005
- Last updated
- 23 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT00232700
- Acronym / sponsor ID
- 20050041
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Sep 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Oct 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.
We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale
Detailed description
We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale compared to placebo.
A second hypothesis is that the treatment of MDE with escitalopram (that means in the "Placebo group") alone lead to typical changes like
- An increase in neurotrophic factors concentration (measured by blood concentrations of nerve growth factor (NGF) and brain derived nerve growth factor (BDNF),
- An increase in hippocampal metabolites (measured with magnetic resonance spectroscopy (MRS
- An increase in motor cortical inhibitory activity (measured with motor evoked potentials (MEP
- An increase in serotonergic activity (measured with EEG parameters, Moreover, it is hypothesized that similar but pronounced changes occur in the group treated with the combination treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major Depressive Episode (according to DSM IV standards)
- HAMD > 20
- Patient has an IQ > 70 based on the investigator´s judgement
- Patient is male or nonpregnant female adequately protected from conception
- Patient is able to comply with all testing and follow-up visit requirements defined by the study protocol
Key exclusion criteria (8 listed)
- Patient has a history of schizophrenia, schizoaffective disorder or delusional disorder
- Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnestic or other cognitive disorder per DSM IV
- Patient is suicidal
- Patient has had an alcohol or substance dependence within the previous 12 month
- Patient is currently enrolled in another investigational study
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 |
|---|---|---|
| Escitalopram | Drug | – |
Primary outcome
Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
4 secondary outcomes
To determine the changes of hippocampal metabolites measured by MRS
To assess the changes of parameters of motor cortical inhibition measured by MEP
To assess the changes of NGF and BDNF
To determine the changes of event related potentials measured by electroencephalography
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 23 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.
Malek Bajbouj, MD principal investigator
Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Major Depressive Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
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 8 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 23 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 Germany. 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.
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?
Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.. 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 23 Jun 2011.