Depression Clinical Trial
Official title:
A Pilot Study of Intermittent Accelerated Burst Transcranial Magnetic Stimulation (aTBS) to Treat Depression: a Randomized, Single-blind, Delayed-start Trial
Verified date | August 2021 |
Source | Institute of Mental Health, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aims of this study are to investigate the efficacy of L DLPFC accelerated TMS (aTMS) in patients with depression in Singapore and to assess the whether a 1-week course of treatment is as effective as a 4-week course of non-accelerated treatment and if additional aTMS or different aTMS treatments will be more efficacious in non-responders to initial aTMS treatment.
Status | Completed |
Enrollment | 38 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Age =21 years. 2. DSM-V diagnosis of current Major Depressive Episode. 3. Montgomery-Asberg Depression Rating Scale score of 20 or more. 4. Able to give informed consent. Exclusion Criteria: 1. DSM-V psychotic disorder. 2. Drug or alcohol abuse or dependence (preceding 3 months). 3. Inadequate response to ECT (current episode of depression). 4. Rapid clinical response required, e.g. high suicide risk. 5. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy. 6. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device. 7. Pregnancy. |
Country | Name | City | State |
---|---|---|---|
Singapore | Institute of Mental Health | Singapore | |
Singapore | Institute of Mental Health | Singapore |
Lead Sponsor | Collaborator |
---|---|
Institute of Mental Health, Singapore |
Singapore,
Tor PC, Galvez V, Goldstein J, George D, Loo CK. Pilot Study of Accelerated Low-Frequency Right-Sided Transcranial Magnetic Stimulation for Treatment-Resistant Depression. J ECT. 2016 Sep;32(3):180-2. doi: 10.1097/YCT.0000000000000306. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS) | The MADRS is a 0-60 point scale to measure depression severity with a higher number indicating more severe depression. Remission from depression is defined as 10 or less. Moderate to severe depression is defined as 20 or more. | 3 weeks | |
Secondary | Remission as assessed by The Montgomery-Åsberg Depression Rating Scale (MADRS) | A MADRS score of 10 or less. | 6 weeks |
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