Major DepressionPhase 2FORESEEIINCT01778790
Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression
A Phase 2 study testing Deep Brain Stimulation with Activa PC Multi-program Neurostimulator in people with Major Depression, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main medial forebrain bundle (slMFB). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Deep Brain Stimulation with Activa PC Multi-program Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Jan 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depression (MD), severe, unipolar
- German mother tongue
- Age 20 to 75 Years
- Hamilton Depression Rating Scale (HRSD24) score of > 21
- Global Assessment of Function (GAF) score of < 45
- At least 4 episodes of depression or chronic episode > 2 years
Show all 13Show 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
- Compliance to participate in the study
- Drug free or on stable drug regimen at least 6 weeks before study entry
Who cannot join
- Current or past non-affective 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
- Acute suicidal tendency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Efficacy, Safety and Effects on Quality of Life of Deep Brain Stimulation to the Medial Forebrain Bundle in Patients With Treatment Resistant Major Depression (FORESEE II: FOREbrain Stimulation dEprEssion)
The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main medial forebrain bundle (slMFB).
Read the detailed description
The target point for DBS in major depression disorder is located lateral to the ventral tegmental area (VTA) in the midbrain at the branching point of the superolateral branch (slMFB) from the main medial forebrain bundle (MFB).
The exact stimulation coordinates are:
Montreal Neurologic Institute brain 152 coordinates (MNI152 coordinates):
left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9
Mid-commissural point coordinates (MCP coordinates):
eft: x(lat.)=-6, y(ap)=-1, z(vert.)=-6 right: x(lat.)=4, y(ap)=-1, z(vert.)=-7
All coordinates refer to the MNI152 brain.
Legend:
slMFB = superolateral branch of medial forebrain bundle lat. = lateral, ap= anteroposterior, vert. = vertical.
More information can be found at: http://goo.gl/n9sWV
- Conditions
- Major Depression
- Being tested
- Deep Brain Stimulation with Activa PC Multi-program Neurostimulator
- 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.
Deep Brain Stimulation with Activa PC Multi-program NeurostimulatorDevice
Device: DBS 130 Hertz (Hz) frequency, 90us pulsewidth, 4 Volt (V) currency Amplitude
Device: DBS - No Stimulation (Sham) 130 Hertz (Hz)frequency, 90us pulsewidth, 0 Volt (V) currency Amplitude
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation for 8 weeks | Sham comparator | Implantation of internal pulse generator (IPG), Sham Stimulation Receives: Device: Deep Brain Stimulation with Activa PC Multi-program Neurostimulator |
| Stimulation for 8 weeks | Active comparator | Implantation of IPG and active stimulation Receives: Device: Deep Brain Stimulation with Activa PC Multi-program Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity assessed with Montgomery Asberg Depression Scale (MADRS)
Change in MADRS after 6 and 12 months as compared to mean baseline score and one month placebo treatment. MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It is used as an adjunct to the Hamilton Rating Scale for Depression (HAMD) and more sensitive to the changes in depression than the Hamilton Scale is.
Measured: 6 and 12 month after DBS stimulation onset
Secondary outcomes (1)
Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)
The Hamilton Rating Scale for Depression (HRSD), also known as the Hamilton Depression Rating Scale (HDRS) or abbreviated to HAM-D, is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. The questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. The questionnaire is presently one of the most commonly used scales for rating depression in medical research.
Measures will be taken at same time points as primary outcome measure.
Measured: 6 and 12 month after DBS stimulation onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Model description
- Deep Brain Stimulation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas E. Schlaepfer, MD, University Hospital, Bonn
- Investigators
- Thomas E. Schlaepfer, MD, Principal investigator, University Hospital, BonnVolker Coenen, MD, Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778790
- Sponsor's protocol ID
- BSG-13-2319DBS
- Acronym
- FORESEEII
- Status last verified
- Aug 2018
- First submitted
- 18 Jan 2013
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kilian HM, Meyer DM, Bewernick BH, Spanier S, Coenen VA, Schlaepfer TE. Discontinuation of Superolateral Medial Forebrain Bundle Deep Brain Stimulation for Treatment-Resistant Depression Leads to Critical Relapse. Biol Psychiatry. 2019 Mar 15;85(6):e23-e24. doi: 10.1016/j.biopsych.2018.07.025. Epub 2018 Sep 22. No abstract available.
PubMed 30253883
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy, Safety and Effects on Quality of Life of Deep Brain Stimulation to the Medial Forebrain Bundle in Patients With Treatment Resistant Major Depression (FORESEE II: FOREbrain Stimulation dEprEssion)
- ClinicalTrials.gov ID
- NCT01778790
- Acronym / sponsor ID
- FORESEEII / BSG-13-2319DBS
- Conditions
- Major Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 Jan 2013 (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.
The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main medial forebrain bundle (slMFB).
Detailed description
The target point for DBS in major depression disorder is located lateral to the ventral tegmental area (VTA) in the midbrain at the branching point of the superolateral branch (slMFB) from the main medial forebrain bundle (MFB).
The exact stimulation coordinates are:
Montreal Neurologic Institute brain 152 coordinates (MNI152 coordinates):
left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9
Mid-commissural point coordinates (MCP coordinates):
eft: x(lat.)=-6, y(ap)=-1, z(vert.)=-6 right: x(lat.)=4, y(ap)=-1, z(vert.)=-7
All coordinates refer to the MNI152 brain.
Legend:
slMFB = superolateral branch of medial forebrain bundle lat. = lateral, ap= anteroposterior, vert. = vertical.
More information can be found at: http://goo.gl/n9sWV
Study design
- Primary purpose
- Treatment
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Deep Brain Stimulation
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation for 8 weeks | Sham comparator | Device: Deep Brain Stimulation with Activa PC Multi-program NeurostimulatorImplantation of internal pulse generator (IPG), Sham Stimulation |
| Stimulation for 8 weeks | Active comparator | Device: Deep Brain Stimulation with Activa PC Multi-program NeurostimulatorImplantation of IPG and active stimulation |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Major depression (MD), severe, unipolar
- German mother tongue
- Age 20 to 75 Years
- Hamilton Depression Rating Scale (HRSD24) score of > 21
- Global Assessment of Function (GAF) score of < 45
Key exclusion criteria (8 listed)
- Current or past non-affective 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 Activa PC Multi-program NeurostimulatorDevice: DBS 130 Hertz (Hz) frequency, 90us pulsewidth, 4 Volt (V) currency Amplitude Device: DBS - No Stimulation (Sham) 130 Hertz (Hz)frequency, 90us pulsewidth, 0 Volt (V) currency Amplitude | Device | Sham Stimulation for 8 weeks, Stimulation for 8 weeks |
Primary outcome
Depression Severity assessed with Montgomery Asberg Depression Scale (MADRS)
Time frame: 6 and 12 month after DBS stimulation onset
Change in MADRS after 6 and 12 months as compared to mean baseline score and one month placebo treatment. MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It is used as an adjunct to the Hamilton Rating Scale for Depression (HAMD) and more sensitive to the changes in depression than the Hamilton Scale is.
1 secondary outcome
Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)
Time frame: 6 and 12 month after DBS 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 7 Aug 2018.
- Derived from this study: PubMed 30253883Kilian HM, Meyer DM, Bewernick BH, Spanier S, Coenen VA, Schlaepfer TE. Discontinuation of Superolateral Medial Forebrain Bundle Deep Brain Stimulation for Treatment-Resistant Depression Leads to Critical Relapse. Biol Psychiatry. 2019 Mar 15;85(6):e23-e24. doi: 10.1016/j.biopsych.2018.07.025. Epub 2018 Sep 22. No abstract available.
- DBS target site descriptionLink 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.
Thomas E. Schlaepfer, MD principal investigator
University Hospital, Bonn
Volker Coenen, MD principal investigator
University Hospital Freiburg
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 Deep Brain Stimulation with Activa PC Multi-program Neurostimulator in people with Major 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 13 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 7 Aug 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.
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?
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 Severity assessed with Montgomery Asberg Depression Scale (MADRS) (time frame: 6 and 12 month after DBS 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 NCT01778790, which also lists 1 linked publication.
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 7 Aug 2018.