Treatment Resistant DepressionBDDSNCT00531726
Berlin Deep Brain Stimulation Depression Study
A study testing DBS of Cg25 in people with Treatment Resistant Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. In addition, the stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will be assessed. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- DBS of Cg25
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Sep 2013
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient is diagnosed with a severe major depressive episode
- patient is in a chronic current MDE and/or has had a history of recurrent MDEs
- patient has not had an acceptable clinical response due to failure with at least three antidepressant treatments during the current episode.
- patient has a score > 20 on the HAMD24
- patient is stable on current psychotropic medication for at least 6 weeks
- patient is >25 and <80 years
- Global Assessment of Function (GAF) score of < 45
Who cannot join
- Atypical Depression (according to DSM IV)
- Other relevant psychiatric axis I or axis II diseases
- Relevant neurological diseases
- Relevant cardiac or pulmonary diseases with enhances anaesthesiological risk (ASA Score > 3)
- Patient is currently enrolled in another investigational study not associated with the current study
- Patient has a history of, or evidence of, significant brain malformation or significant head injury
- Patient is likely to require a whole body MRI after implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Efficacy and Safety of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression in a Multicenter, Double-blind, Prospectivly-designed Delayed-onset Study (Tiefe Hirnstimulation Zur Behandlung Therapieresistenter Depressionen-eine Multizentrische, Doppelblinde, Prospektive Studie Mit Einem Delayed-onset Design)
In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. In addition, the stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will be assessed.
- Conditions
- Treatment Resistant Depression
- Being tested
- DBS of Cg25
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS of Cg25Device
| Study group | Role | What they receive |
|---|---|---|
| B | Sham comparator | Not described Receives: Device: DBS of Cg25 |
| A | Experimental | Not described Receives: Device: DBS of Cg25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD/MARS score reduction
Measured: 4 weeks
Secondary outcomes (1)
neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Carl Gustav Carus, Ludwig-Maximilians - University of Munich, Hannover Medical School
- Responsible party
- Principal investigator, Malek Bajbouj, Charite University, Berlin, Germany
- Investigators
- Malek Bajbouj, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531726
- Sponsor's protocol ID
- BDDS
- Acronym
- BDDS
- Status last verified
- Jan 2018
- First submitted
- 18 Sep 2007
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Efficacy and Safety of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression in a Multicenter, Double-blind, Prospectivly-designed Delayed-onset Study (Tiefe Hirnstimulation Zur Behandlung Therapieresistenter Depressionen-eine Multizentrische, Doppelblinde, Prospektive Studie Mit Einem Delayed-onset Design)
- ClinicalTrials.gov ID
- NCT00531726
- Acronym / sponsor ID
- BDDS / BDDS
- Conditions
- Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University Hospital Carl Gustav Carus, Ludwig-Maximilians - University of Munich, Hannover Medical School
- Study start
- Sep 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Sep 2007 (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.
In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. In addition, the stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Sham comparator | Device: DBS of Cg25 |
| A | Experimental | Device: DBS of Cg25 |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patient is diagnosed with a severe major depressive episode
- patient is in a chronic current MDE and/or has had a history of recurrent MDEs
- patient has not had an acceptable clinical response due to failure with at least three antidepressant treatments during the current episode.
- patient has a score > 20 on the HAMD24
- patient is stable on current psychotropic medication for at least 6 weeks
Key exclusion criteria (7 listed)
- Atypical Depression (according to DSM IV)
- Other relevant psychiatric axis I or axis II diseases
- Relevant neurological diseases
- Relevant cardiac or pulmonary diseases with enhances anaesthesiological risk (ASA Score > 3)
- Patient is currently enrolled in another investigational study not associated with the current 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 |
|---|---|---|
| DBS of Cg25 | Device | A, B |
Primary outcome
HAMD/MARS score reduction
Time frame: 4 weeks
1 secondary outcome
neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures
Time frame: 4 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 24 Jan 2018.
- contact: stimulation@charite.deLink provided by the sponsor.
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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 study director
Charite University, 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 DBS of Cg25 in people with Treatment Resistant Depression, 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 7 inclusion and 7 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 24 Jan 2018. 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. 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?
HAMD/MARS score reduction (time frame: 4 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 24 Jan 2018.