Depressive DisorderPhase 3rtmsNCT00044798
Magnetic Stimulation Therapy for Treating Vascular Depression
A Phase 3 study testing Repetitive transcranial magnetic stimulation (rTMS) and Citalopram in people with Depressive Disorder and Depression, run by University of Iowa at 1 site in United States.
Trial summary
This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of depression associated with small vascular lesions in the brain (vascular depression). Read more about this study
- Who is it for?
- Ages 51 to 89 years
- Conditions the study is for
- Depressive Disorder, Depression
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS) and Citalopram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2008
- 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 51 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of unipolar major or minor depressive disorder
- Hamilton Depression Rating Scale score of at least 18
- Depression that is associated with cerebrovascular disease
- Failed at least 1 treatment for vascular depression
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Health Care
Iowa City, Iowa, 52242-1087
About this study
Official title: Vascular Depression and Magnetic Stimulation Therapy
This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of depression associated with small vascular lesions in the brain (vascular depression).
Read the detailed description
Vascular depression is a condition that typically affects the elderly and is associated with small vascular lesions. It is more resistant to treatment and has a poorer outcome than nonvascular depression. By altering excitability in the cortical area of the brain, rTMS may be an effective treatment neuropsychiatric conditions, particularly depression.
Participants in this study will be randomly assigned to 15 treatments of either rTMS or sham rTMS for 3 weeks. Following treatment, participants will receive citalopram for 9 weeks. Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy will be measured. Improvements in activities of daily living, quality of life, and cognitive function will also be also measured.
- Conditions
- Depressive Disorder, Depression
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS), Citalopram, Sham rTMS
- Keywords
- Aged
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Procedure or surgery
Participants will receive 15 treatments of rTMS over 3 weeks.
CitalopramDrug
After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.
Sham rTMSProcedure or surgery
Participants will receive 15 treatments of sham rTMS over 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram. Receives: Procedure: Repetitive transcranial magnetic stimulation (rTMS); Drug: Citalopram |
| 2 | Active comparator | Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram. Receives: Drug: Citalopram; Procedure: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy
Measured: Measured at Week 12
Secondary outcomes (1)
Improvements in activities of daily living, quality of life, and cognitive function
Measured: Measured at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2002 (estimated)
- Study startSep 2001
- Primary completionMar 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044798
- Sponsor's protocol ID
- R01MH063405
- Other IDs
- R01MH063405, DATR A4-GPX
- Acronym
- rtms
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2002
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Depression and Magnetic Stimulation Therapy
- ClinicalTrials.gov ID
- NCT00044798
- Acronym / sponsor ID
- rtms / R01MH063405
- Conditions
- Depressive Disorder, Depression
- Keywords
- Aged
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Primary completion
- Mar 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Sep 2002 (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.
This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of depression associated with small vascular lesions in the brain (vascular depression).
Detailed description
Vascular depression is a condition that typically affects the elderly and is associated with small vascular lesions. It is more resistant to treatment and has a poorer outcome than nonvascular depression. By altering excitability in the cortical area of the brain, rTMS may be an effective treatment neuropsychiatric conditions, particularly depression.
Participants in this study will be randomly assigned to 15 treatments of either rTMS or sham rTMS for 3 weeks. Following treatment, participants will receive citalopram for 9 weeks. Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy will be measured. Improvements in activities of daily living, quality of life, and cognitive function will also be also measured.
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 | Procedure: Repetitive transcranial magnetic stimulation (rTMS), Drug: CitalopramParticipants will receive treatment with repetitive transcranial magnetic stimulation and citalopram. |
| 2 | Active comparator | Drug: Citalopram, Procedure: Sham rTMSParticipants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram. |
Who may qualify
- Ages
- 51 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of unipolar major or minor depressive disorder
- Hamilton Depression Rating Scale score of at least 18
- Depression that is associated with cerebrovascular disease
- Failed at least 1 treatment for vascular depression
Key exclusion criteria (0 listed)
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 (rTMS)Participants will receive 15 treatments of rTMS over 3 weeks. | Procedure or surgery | 1 |
| CitalopramAfter completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks. | Drug | 1, 2 |
| Sham rTMSParticipants will receive 15 treatments of sham rTMS over 3 weeks. | Procedure or surgery | 2 |
Primary outcome
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy
Time frame: Measured at Week 12
1 secondary outcome
Improvements in activities of daily living, quality of life, and cognitive function
Time frame: Measured at Week 12
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 27 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Repetitive transcranial magnetic stimulation (rTMS) and Citalopram in people with Depressive Disorder and Depression, run by University of Iowa 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?
The sponsor lists 4 inclusion and 0 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 27 Sep 2013. 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 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?
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy (time frame: Measured at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2013.