Unipolar DepressionPhase 3NCT00914680
Berlin Magnetic Seizure Therapy Depression Trial 01
A Phase 3 study testing magnetic seizure therapy in people with Unipolar Depression and Bipolar Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The investigators will perform add-on tests to assess clinical and cognitive response to treatment. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Unipolar Depression, Bipolar Depression
- What is being tested?
- magnetic seizure therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to May 2013
- Phase
- Phase 3
- 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 2 antidepressant treatments during the current episode
- Patient has a score > 20 on the HAMD24
- Patient is stable on current psychotropic medication for at least 4 weeks
- Patient is > 25 and < 80 years
Who cannot join
- Atypical Depression or psychotic depression (according to DSM IV)
- Other relevant psychiatric axis I or axis II diseases
- Relevant neurological diseases
- Relevant cardiac or pulmonary diseases with enhances anesthesiological 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, CC15, CBF, Eschenallee 3
Berlin, 14050
About this study
Official title: Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression
This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The investigators will perform add-on tests to assess clinical and cognitive response to treatment. It is hypothesized that MST will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.
- Conditions
- Unipolar Depression, Bipolar Depression
- Being tested
- magnetic seizure therapy
- Medical subject headings
- Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic seizure therapyProcedure or surgery
antidepressant treatment with MST
| Study group | Role | What they receive |
|---|---|---|
| MST | Experimental | Not described Receives: Procedure: magnetic seizure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement (HAMD)
Measured: before, after treatment
Secondary outcomes (1)
Neurocognitive performance
Measured: before/after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malek Bajbouj, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914680
- Sponsor's protocol ID
- BEMAST1
- Status last verified
- Jul 2018
- First submitted
- 3 Jun 2009
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT00914680
- Acronym / sponsor ID
- BEMAST1
- Conditions
- Unipolar Depression, Bipolar Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Jun 2009 (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 treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The investigators will perform add-on tests to assess clinical and cognitive response to treatment. It is hypothesized that MST will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MST | Experimental | Procedure: magnetic seizure therapy |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 2 antidepressant treatments during the current episode
- Patient has a score > 20 on the HAMD24
- Patient is stable on current psychotropic medication for at least 4 weeks
Key exclusion criteria (6 listed)
- Atypical Depression or psychotic depression (according to DSM IV)
- Other relevant psychiatric axis I or axis II diseases
- Relevant neurological diseases
- Relevant cardiac or pulmonary diseases with enhances anesthesiological 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 |
|---|---|---|
| magnetic seizure therapyantidepressant treatment with MST | Procedure or surgery | MST |
Primary outcome
Clinical Improvement (HAMD)
Time frame: before, after treatment
1 secondary outcome
Neurocognitive performance
Time frame: before/after treatment
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 13 Jul 2018.
- Related InfoLink provided by the sponsor.
Related trials for Unipolar Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing magnetic seizure therapy in people with Unipolar Depression and Bipolar 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 6 inclusion and 6 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 13 Jul 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical Improvement (HAMD) (time frame: before, after treatment). 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 13 Jul 2018.