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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Re5 Pulsating ElectroMagnetic Fields | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton depression rating scale | Interviewer based rating scale to measure severity of depression | Every week for 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| UKU | Side effect scale | Every week for 11 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Lunde, Coordinator | Mental Health Centre North Zealand Psychiatric Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Research Unit, Mental Health Centre North Zealand | Hilleroed | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20385376 | Background | 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. | |
| 26242577 | Derived | Bech 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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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Re5 Pulsating ElectroMagnetic Fields (PEMF) | Device | Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon) |
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