DepressionPhase 3NCT00287703
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
A Phase 3 study testing Pulsating Electro-Magnetic Fields in people with Depression, run by Hillerod Hospital, Denmark at 1 site in Denmark.
Trial summary
About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Pulsating Electro-Magnetic Fields
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2006to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depression
- Treatment resistance
- Age above 18 years
- Hamilton 17 item score above 13
- Unaltered pharmacological treatment in last 4 weeks
Who cannot join
- Psychotic disorder
- Mental retardation
- Suicidality
- Earlier treatment with PEMF
- Abuse of alcohol or other substances
- Patient not able to come to appointed visits
Show all 9Show fewer
- Antisocial, borderline or schizotypic personality disorder
- Women lactating or pregnant
- Unreliable contraception
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Speciallægerne Falkoner Allé
Municipality of Frederiksberg, 2000
About this study
About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields) can alleviate the symptoms of depression.
Read the detailed description
In this study, a patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severity is measured at the beginning of the study and at each weekly visit. Side effects are closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).
- Conditions
- Depression
- Being tested
- Pulsating Electro-Magnetic Fields, Pulsating Electro-Magnetic Fields sham
- Keywords
- Major depression, Treatment resistant, PEMF, AQT, Hamilton
- 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.
Pulsating Electro-Magnetic FieldsDevice
5 days a week for 5 weeks 30 minutes
Pulsating Electro-Magnetic Fields shamDevice
sham PEMF
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active Pulsating Electro Magnetic Fields (PEMF) treatment Receives: Device: Pulsating Electro-Magnetic Fields |
| 2 | Sham comparator | 5 days a week for 5 weeks for 30 minutes Sham PEMF Receives: Device: Pulsating Electro-Magnetic Fields sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale score (depression)
Measured: 1 week
Secondary outcomes (1)
AQT, measure of concentration
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2009
- Study completionMar 2009
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The Lundbeckfoundation, Biofields
- Investigators
- Klaus Martiny, MD, Ph.D., Principal investigator, Psychiatric Research Unit Fredericksburg General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287703
- Sponsor's protocol ID
- Final version 26 Oktober 2005
- Status last verified
- May 2009
- First submitted
- 31 Jan 2006
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10.
PubMed 20385376
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
- ClinicalTrials.gov ID
- NCT00287703
- Acronym / sponsor ID
- Final version 26 Oktober 2005
- Conditions
- Depression
- Keywords
- Major depression, Treatment resistant, PEMF, AQT, Hamilton
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Collaborators
- The Lundbeckfoundation, Biofields
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 Feb 2006 (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.
About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields) can alleviate the symptoms of depression.
Detailed description
In this study, a patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severity is measured at the beginning of the study and at each weekly visit. Side effects are closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Pulsating Electro-Magnetic FieldsActive Pulsating Electro Magnetic Fields (PEMF) treatment |
| 2 | Sham comparator | Device: Pulsating Electro-Magnetic Fields sham5 days a week for 5 weeks for 30 minutes Sham PEMF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major depression
- Treatment resistance
- Age above 18 years
- Hamilton 17 item score above 13
- Unaltered pharmacological treatment in last 4 weeks
Key exclusion criteria (9 listed)
- Psychotic disorder
- Mental retardation
- Suicidality
- Earlier treatment with PEMF
- Abuse of alcohol or other substances
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 |
|---|---|---|
| Pulsating Electro-Magnetic Fields5 days a week for 5 weeks 30 minutes | Device | 1 |
| Pulsating Electro-Magnetic Fields shamsham PEMF | Device | 2 |
Primary outcome
Hamilton Depression Rating Scale score (depression)
Time frame: 1 week
1 secondary outcome
AQT, measure of concentration
Time frame: weekly
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 29 May 2009.
- Derived from this study: PubMed 20385376Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10.
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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.
Klaus Martiny, MD, Ph.D. principal investigator
Psychiatric Research Unit Fredericksburg General Hospital
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 Pulsating Electro-Magnetic Fields in people with Depression, run by Hillerod Hospital, Denmark at 1 site in Denmark.
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 5 inclusion and 9 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 29 May 2009. 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 Denmark. 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 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?
Hamilton Depression Rating Scale score (depression) (time frame: 1 week). 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 NCT00287703, 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 29 May 2009.