DepressionPhase 1NCT00018746
Transcranial Magnetic Stimulation in Depression
A Phase 1 study testing repetitive transcranial magnetic stimulation in people with Depression, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The study examines efficacy of repetitive transcranial magnetic stimulation in treating severely depressed patients who are medicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Jul 2001
- Phase
- Phase 1
- 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
severe treatment-resistant depression
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Efficacy of Threshold vs. Subthreshold TMS in the Treatment of Depression
The study examines efficacy of repetitive transcranial magnetic stimulation in treating severely depressed patients who are medicated.
Read the detailed description
Medicated, treatment resistant, depressed patients are randomized to active or sham repetitive transcranial magnetic stimulation (rTMS). Responding patients go into a six months follow-up period.
- Conditions
- Depression
- Being tested
- repetitive transcranial magnetic stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startJul 1999
- Study completionJul 2001
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 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Ralph HoffmanDan Oren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018746
- Sponsor's protocol ID
- MHBS-037-98S
- Status last verified
- Dec 2004
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Publications
Wu NQ, Gao Z, Zheng Y, Li W, Li JN, Xu HY, Cheng XS, Wu Y, Wang Y, Wang ZJ, Yang JG, Yang YJ; China Acute Myocardial Infarction Registry Study Group. [Status of intra-aortic balloon pump application and related factors in Chinese patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2018 Jan 24;46(1):26-31. doi: 10.3760/cma.j.issn.0253-3758.2018.01.005. Chinese.
PubMed 29374934Fu R, Yang YJ, Dou KF, Yang JG, Gao XJ, Xu HY, Wu Y, Li W, Wang Y, Jia YL, Jin C; China Acute Myocardial Infarction Registry. [Age-related differences in the clinical symptoms and triggering factors among Chinese patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2016 Apr 24;44(4):298-302. doi: 10.3760/cma.j.issn.0253-3758.2016.04.005. Chinese.
PubMed 27112606
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Threshold vs. Subthreshold TMS in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT00018746
- Acronym / sponsor ID
- MHBS-037-98S
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 1999
- Study completion
- Jul 2001
- First posted
- 5 Jul 2001 (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.
The study examines efficacy of repetitive transcranial magnetic stimulation in treating severely depressed patients who are medicated.
Detailed description
Medicated, treatment resistant, depressed patients are randomized to active or sham repetitive transcranial magnetic stimulation (rTMS). Responding patients go into a six months follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation | Device | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
- Derived from this study: PubMed 29374934Wu NQ, Gao Z, Zheng Y, Li W, Li JN, Xu HY, Cheng XS, Wu Y, Wang Y, Wang ZJ, Yang JG, Yang YJ; China Acute Myocardial Infarction Registry Study Group. [Status of intra-aortic balloon pump application and related factors in Chinese patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2018 Jan 24;46(1):26-31. doi: 10.3760/cma.j.issn.0253-3758.2018.01.005. Chinese.
- Derived from this study: PubMed 27112606Fu R, Yang YJ, Dou KF, Yang JG, Gao XJ, Xu HY, Wu Y, Li W, Wang Y, Jia YL, Jin C; China Acute Myocardial Infarction Registry. [Age-related differences in the clinical symptoms and triggering factors among Chinese patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2016 Apr 24;44(4):298-302. doi: 10.3760/cma.j.issn.0253-3758.2016.04.005. Chinese.
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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.
Ralph Hoffman
Dan Oren
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing repetitive transcranial magnetic stimulation in people with Depression, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jan 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00018746, 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 21 Jan 2009.