Treatment Resistant DepressionPhase 3PEMFIINCT01353092
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression
A Phase 3 study testing Re5 Pulsating ElectroMagnetic Fields and Re5 Pulsating ElectroMagnetic Fields (PEMF) in people with Treatment Resistant Depression, run by Hillerod Hospital, Denmark at 1 site in Denmark.
Trial summary
In this study patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Re5 Pulsating ElectroMagnetic Fields and Re5 Pulsating ElectroMagnetic Fields (PEMF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Jun 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment resistant Major depression (grade 3 Sackeim criteria)
- Age above 18 and below 85
- Hamilton (17 item version) score above 12
- Unchanged psychopharmacological treatment for last five weeks.
Who cannot join
- suicidality above 2 on item three on Hamilton scale or,earlier PEMF treatment
- dementia or similar cognitive impairment
- psychotic disorder
- abuse of alcohol or drugs
- pregnant or lactating women
- insufficient birth control measures
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Research Unit, Mental Health Centre North Zealand
Hilleroed, 3400
About this study
Official title: PEMF Treatment in Patients With Treatment Resistant Depression in On-going Antidepressant Drug Therapy. A Randomized, Double-blind, Clinically Controlled, Dose-response PEMF Trial for a Duration of Eight Weeks
In this study patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. In group A patients receive active treatment both morning and afternoon. In group B patients receive one sham and one active treatment. The study is double-blind as neither the assessors or patients are aware of treatment allocation. Each session lasts 30 minutes. Patients are psychometrically assessed weekly for depression severity and side effect. After this intervention period patients are followed for further three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the study period.
- Conditions
- Treatment Resistant Depression
- Being tested
- Re5 Pulsating ElectroMagnetic Fields, Re5 Pulsating ElectroMagnetic Fields (PEMF)
- Keywords
- Randomized Controlled Trial, Major depression, Hamilton, PEMF
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re5 Pulsating ElectroMagnetic FieldsDevice
Also called T-PEMF = Transcranially applied PEMF
Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):
30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon
Re5 Pulsating ElectroMagnetic Fields (PEMF)Device
Also called T-PEMF = Transcranially applied PEMF
Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):
30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
| Study group | Role | What they receive |
|---|---|---|
| Active PEMF twice daily | Experimental | Re5 treatment helmet using Pulsating ElectroMagnetic Field:
Intervention: 30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon Receives: Device: Re5 Pulsating ElectroMagnetic Fields |
| Active PEMF once daily | Active comparator | Re5 treatment helmet using Pulsating ElectroMagnetic Field:
Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon) Receives: Device: Re5 Pulsating ElectroMagnetic Fields (PEMF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton depression rating scale
Interviewer based rating scale to measure severity of depression
Measured: Every week for 11 weeks
Secondary outcomes (1)
UKU
Side effect scale
Measured: Every week for 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Bech, Hillerod Hospital, Denmark
- Investigators
- Marianne Lunde, Coordinator, Principal investigator, Mental Health Centre North Zealand Psychiatric Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353092
- Sponsor's protocol ID
- 26.04.2010
- Acronym
- PEMFII
- Status last verified
- Aug 2015
- First submitted
- 27 Apr 2011
- Last updated
- 26 Aug 2015
- 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 20385376Bech P, Timmerby N, Martiny K, Lunde M, Soendergaard S. Psychometric evaluation of the Major Depression Inventory (MDI) as depression severity scale using the LEAD (Longitudinal Expert Assessment of All Data) as index of validity. BMC Psychiatry. 2015 Aug 5;15:190. doi: 10.1186/s12888-015-0529-3.
PubMed 26242577
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEMF Treatment in Patients With Treatment Resistant Depression in On-going Antidepressant Drug Therapy. A Randomized, Double-blind, Clinically Controlled, Dose-response PEMF Trial for a Duration of Eight Weeks
- ClinicalTrials.gov ID
- NCT01353092
- Acronym / sponsor ID
- PEMFII / 26.04.2010
- Conditions
- Treatment Resistant Depression
- Keywords
- Randomized Controlled Trial, Major depression, Hamilton, PEMF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 May 2011 (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 patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. In group A patients receive active treatment both morning and afternoon. In group B patients receive one sham and one active treatment. The study is double-blind as neither the assessors or patients are aware of treatment allocation. Each session lasts 30 minutes. Patients are psychometrically assessed weekly for depression severity and side effect. After this intervention period patients are followed for further three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the study period.
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 |
|---|---|---|
| Active PEMF twice daily | Experimental | Device: Re5 Pulsating ElectroMagnetic FieldsRe5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon |
| Active PEMF once daily | Active comparator | Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treatment resistant Major depression (grade 3 Sackeim criteria)
- Age above 18 and below 85
- Hamilton (17 item version) score above 12
- Unchanged psychopharmacological treatment for last five weeks.
Key exclusion criteria (6 listed)
- suicidality above 2 on item three on Hamilton scale or,earlier PEMF treatment
- dementia or similar cognitive impairment
- psychotic disorder
- abuse of alcohol or drugs
- pregnant or lactating women
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 |
|---|---|---|
| Re5 Pulsating ElectroMagnetic FieldsAlso: T-PEMF = Transcranially applied PEMFRe5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon | Device | Active PEMF twice daily |
| Re5 Pulsating ElectroMagnetic Fields (PEMF)Also: T-PEMF = Transcranially applied PEMFRe5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon) | Device | Active PEMF once daily |
Primary outcome
Hamilton depression rating scale
Time frame: Every week for 11 weeks
Interviewer based rating scale to measure severity of depression
1 secondary outcome
UKU
Time frame: Every week for 11 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 26 Aug 2015.
- Background: 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.
- Derived from this study: PubMed 26242577Bech P, Timmerby N, Martiny K, Lunde M, Soendergaard S. Psychometric evaluation of the Major Depression Inventory (MDI) as depression severity scale using the LEAD (Longitudinal Expert Assessment of All Data) as index of validity. BMC Psychiatry. 2015 Aug 5;15:190. doi: 10.1186/s12888-015-0529-3.
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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.
Marianne Lunde, Coordinator principal investigator
Mental Health Centre North Zealand Psychiatric Research Unit
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 Re5 Pulsating ElectroMagnetic Fields and Re5 Pulsating ElectroMagnetic Fields (PEMF) in people with Treatment Resistant 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 4 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 26 Aug 2015. 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. 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 (time frame: Every week for 11 weeks). 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 NCT01353092, which also lists 2 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 26 Aug 2015.