DepressionPhase 1NCT00122031
Deep Brain Stimulation for Treatment-Refractory Major Depression
A Phase 1 study testing Deep Brain Stimulation with Medtronic Activa Neurostimulator in people with Depression, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
This study will investigate the use of deep brain stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-refractory major depression. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Deep Brain Stimulation with Medtronic Activa Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2005to Jan 2011
- Phase
- Phase 1
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depression (MD), severe, unipolar type
- German mother tongue
- Hamilton Depression Rating Scale (HDRS24) score of > 20
- Global Assessment of Function (GAF) score of < 45
- At least 4 episodes of MD or chronic episode > 2 years
- > 5 years after first episode of MD
Show all 11Show fewer
- Failure to respond to *adequate trials (>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes;
- adequate trials (>3 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant); *an adequate trial of electroconvulsive therapy [ECT] (>6 bilateral treatments) and; *an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
- Able to give written informed consent
- No medical comorbidity
- Drug free or on stable drug regimen at least 6 weeks before study entry
Who cannot join
- Current or past nonaffective psychotic disorder
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
- Any surgical contraindications to undergoing DBS
- Current or unstably remitted substance abuse (aside from nicotine)
- Pregnancy and women of childbearing age not using effective contraception
- History of severe personality disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Bonn
Bonn, 53105
About this study
This study will investigate the use of deep brain stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-refractory major depression.
Read the detailed description
Despite advances in pharmacotherapy and psychotherapy for major depression, a substantial number of patients fail to improve significantly even after years of conventional and experimental interventions. Bilateral deep brain stimulation (DBS) to the region of the anterior capsule/ventral striatum is an adjustable and reversible procedure that may be a more effective treatment for patients with major depression. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory major depression.
- Conditions
- Depression
- Being tested
- Deep Brain Stimulation with Medtronic Activa Neurostimulator
- Keywords
- Major Depression, Treatment Refractory Major Depression
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation with Medtronic Activa NeurostimulatorDevice
Also called Activa Neurostimulator
Deep brain stimulation (DBS) at 130 Hz
| Study group | Role | What they receive |
|---|---|---|
| DBS | Experimental | Not described Receives: Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
Measured: analyzed at 12 and 24 month after stimulation onset
Secondary outcomes (1)
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: analyzed at 12 and 24 month after stimulation onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionApr 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Thomas E. Schlaepfer, MD, University Hospital, Bonn
- Investigators
- Thomas E Schlaepfer, MD, Principal investigator, University of BonnVolker Sturm, MD, Study director, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122031
- Sponsor's protocol ID
- BSG-04-006
- Status last verified
- Jun 2012
- First submitted
- 15 Jul 2005
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen MX, Axmacher N, Lenartz D, Elger CE, Sturm V, Schlaepfer TE. Good vibrations: cross-frequency coupling in the human nucleus accumbens during reward processing. J Cogn Neurosci. 2009 May;21(5):875-89. doi: 10.1162/jocn.2009.21062.
PubMed 18702577Lieb K, Schlaepfer TE. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Nov 23;355(21):2256; author reply 2256. doi: 10.1056/NEJMc062545. No abstract available.
PubMed 17124028Kosel M, Sturm V, Frick C, Lenartz D, Zeidler G, Brodesser D, Schlaepfer TE. Mood improvement after deep brain stimulation of the internal globus pallidus for tardive dyskinesia in a patient suffering from major depression. J Psychiatr Res. 2007 Nov;41(9):801-3. doi: 10.1016/j.jpsychires.2006.07.010. Epub 2006 Sep 8.
PubMed 16962613Schlaepfer TE, Cohen MX, Frick C, Kosel M, Brodesser D, Axmacher N, Joe AY, Kreft M, Lenartz D, Sturm V. Deep brain stimulation to reward circuitry alleviates anhedonia in refractory major depression. Neuropsychopharmacology. 2008 Jan;33(2):368-77. doi: 10.1038/sj.npp.1301408. Epub 2007 Apr 11.
PubMed 17429407Bewernick BH, Hurlemann R, Matusch A, Kayser S, Grubert C, Hadrysiewicz B, Axmacher N, Lemke M, Cooper-Mahkorn D, Cohen MX, Brockmann H, Lenartz D, Sturm V, Schlaepfer TE. Nucleus accumbens deep brain stimulation decreases ratings of depression and anxiety in treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):110-6. doi: 10.1016/j.biopsych.2009.09.013.
PubMed 19914605Bewernick BH, Kayser S, Sturm V, Schlaepfer TE. Long-term effects of nucleus accumbens deep brain stimulation in treatment-resistant depression: evidence for sustained efficacy. Neuropsychopharmacology. 2012 Aug;37(9):1975-85. doi: 10.1038/npp.2012.44. Epub 2012 Apr 4.
PubMed 22473055Grubert C, Hurlemann R, Bewernick BH, Kayser S, Hadrysiewicz B, Axmacher N, Sturm V, Schlaepfer TE. Neuropsychological safety of nucleus accumbens deep brain stimulation for major depression: effects of 12-month stimulation. World J Biol Psychiatry. 2011 Oct;12(7):516-27. doi: 10.3109/15622975.2011.583940. Epub 2011 Jul 8.
PubMed 21736514
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for Treatment-Refractory Major Depression
- ClinicalTrials.gov ID
- NCT00122031
- Acronym / sponsor ID
- BSG-04-006
- Conditions
- Depression
- Keywords
- Major Depression, Treatment Refractory Major Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jul 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 Jul 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.
This study will investigate the use of deep brain stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-refractory major depression.
Detailed description
Despite advances in pharmacotherapy and psychotherapy for major depression, a substantial number of patients fail to improve significantly even after years of conventional and experimental interventions. Bilateral deep brain stimulation (DBS) to the region of the anterior capsule/ventral striatum is an adjustable and reversible procedure that may be a more effective treatment for patients with major depression. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory major depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS | Experimental | Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Major depression (MD), severe, unipolar type
- German mother tongue
- Hamilton Depression Rating Scale (HDRS24) score of > 20
- Global Assessment of Function (GAF) score of < 45
- At least 4 episodes of MD or chronic episode > 2 years
Key exclusion criteria (7 listed)
- Current or past nonaffective psychotic disorder
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
- Any surgical contraindications to undergoing DBS
- Current or unstably remitted substance abuse (aside from nicotine)
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 |
|---|---|---|
| Deep Brain Stimulation with Medtronic Activa NeurostimulatorAlso: Activa NeurostimulatorDeep brain stimulation (DBS) at 130 Hz | Device | DBS |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: analyzed at 12 and 24 month after stimulation onset
1 secondary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: analyzed at 12 and 24 month after stimulation onset
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 14 Jun 2012.
- Background: PubMed 18702577Cohen MX, Axmacher N, Lenartz D, Elger CE, Sturm V, Schlaepfer TE. Good vibrations: cross-frequency coupling in the human nucleus accumbens during reward processing. J Cogn Neurosci. 2009 May;21(5):875-89. doi: 10.1162/jocn.2009.21062.
- Background: PubMed 17124028Lieb K, Schlaepfer TE. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Nov 23;355(21):2256; author reply 2256. doi: 10.1056/NEJMc062545. No abstract available.
- Background: PubMed 16962613Kosel M, Sturm V, Frick C, Lenartz D, Zeidler G, Brodesser D, Schlaepfer TE. Mood improvement after deep brain stimulation of the internal globus pallidus for tardive dyskinesia in a patient suffering from major depression. J Psychiatr Res. 2007 Nov;41(9):801-3. doi: 10.1016/j.jpsychires.2006.07.010. Epub 2006 Sep 8.
- Results publication: PubMed 17429407Schlaepfer TE, Cohen MX, Frick C, Kosel M, Brodesser D, Axmacher N, Joe AY, Kreft M, Lenartz D, Sturm V. Deep brain stimulation to reward circuitry alleviates anhedonia in refractory major depression. Neuropsychopharmacology. 2008 Jan;33(2):368-77. doi: 10.1038/sj.npp.1301408. Epub 2007 Apr 11.
- Results publication: PubMed 19914605Bewernick BH, Hurlemann R, Matusch A, Kayser S, Grubert C, Hadrysiewicz B, Axmacher N, Lemke M, Cooper-Mahkorn D, Cohen MX, Brockmann H, Lenartz D, Sturm V, Schlaepfer TE. Nucleus accumbens deep brain stimulation decreases ratings of depression and anxiety in treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):110-6. doi: 10.1016/j.biopsych.2009.09.013.
- Results publication: PubMed 22473055Bewernick BH, Kayser S, Sturm V, Schlaepfer TE. Long-term effects of nucleus accumbens deep brain stimulation in treatment-resistant depression: evidence for sustained efficacy. Neuropsychopharmacology. 2012 Aug;37(9):1975-85. doi: 10.1038/npp.2012.44. Epub 2012 Apr 4.
- Derived from this study: PubMed 21736514Grubert C, Hurlemann R, Bewernick BH, Kayser S, Hadrysiewicz B, Axmacher N, Sturm V, Schlaepfer TE. Neuropsychological safety of nucleus accumbens deep brain stimulation for major depression: effects of 12-month stimulation. World J Biol Psychiatry. 2011 Oct;12(7):516-27. doi: 10.3109/15622975.2011.583940. Epub 2011 Jul 8.
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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.
Thomas E Schlaepfer, MD principal investigator
University of Bonn
Volker Sturm, MD study director
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deep Brain Stimulation with Medtronic Activa Neurostimulator in people with Depression, run by University Hospital, Bonn 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 11 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 14 Jun 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hamilton Depression Rating Scale (HDRS) (time frame: analyzed at 12 and 24 month after stimulation onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122031, which also lists 7 linked publications.
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 14 Jun 2012.