DepressionNCT01516931
Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Depression
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) and counseling in people with Depression, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- repetitive Transcranial Magnetic Stimulation (rTMS) and counseling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 25 Feb 2017
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of depression
- Experiencing an acute exacerbation of depression symptoms
- Baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items
- Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
Who cannot join
- Comprised ferromagnetic metallic implants
- Pacemakers
- Previous neurosurgery
- History of seizures
- Major head trauma
- Alcoholism
Show all 10Show fewer
- Drug addiction
- Any psychiatric or neurological disorder other than depression and anxiety
- Psychotic depression
- Suicidal propensities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Depression.
The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale.
Read the detailed description
Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of depression.Depression is a chronic illness and generally requires life-long treatment. However, up to current days there have been no studies evaluating the effects of rTMS in the maintenance treatment of depression. This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of rTMS, as monotherapy, relative to placebo in delaying the time to relapse in patients with depression. Patients with acute symptoms of depression will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose stabilization period, and a 12 months double-blind relapse prevention period. The study will consist of 4 phases: a screening/tolerability phase of up to 7 days; an open-label, flexible-dose lead-in phase of 8 weeks; an open-label, fixed-dose stabilization phase of 6 weeks; and a single-blind relapse prevention phase of 12 months. During the open-label phase, all patients will be treated with venlafaxine. Remitterswith Hamilton Rating Scale for Depression [HAM-D17] score ≤ 7will be eligible to enter the single-blind phase and will be randomly assigned to one of three groups: group 1 on active rTMS and venlafaxine; group 2 on sham rTMS and venlafaxine; group 3 on venlafaxine alone. Efficacy will be evaluated during the study using relapse assessment (time between subject randomization to treatment and the first occurrence of relapse). Secondary outcome measures will include: symptom changes, measured by the Hamilton Rating Scale for Depression [HAM-D17]; illness severity changes, measured by the Clinical Global Impression of Severity for Depression (CGI-S-DEP); and changes in subject functioning, assessed with the Personal and Social Performance Scale. Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiography, and measurements of vital signs (temperature, pulse and blood pressure) and weight. Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study.
- Conditions
- Depression
- Being tested
- repetitive Transcranial Magnetic Stimulation (rTMS), counseling
- Keywords
- repetitive Transcranial Magnetic Stimulation (rTMS), Depression, Venlafaxine, Relapse
- Medical subject headings
- Depression, Recurrence
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
1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks
counselingBehavioural
Placebo monthly by general counseling for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| active rTMS and venlafaxine | Experimental | rTMS：Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.
venlafaxine：150-225mg/day Receives: Procedure: repetitive Transcranial Magnetic Stimulation (rTMS) |
| sham rTMS and venlafaxine | Placebo comparator | Sham stimulation will be given at the same site and frequency, using a Magstim sham-coil system. During rTMS, participants will be instructed to keep their eyes open and relax. Receives: Behavioral: counseling |
| venlafaxine alone | Placebo comparator | responders will be maintained on the same effective dose of venlafaxine for the entire duration of the RCT, unless they relapse and will have to exit the protocol and enter a naturalistic follow-up Receives: Behavioral: counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for relapse
Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period
Measured: Participants will be followed for the duration of 15 month double-blind Relapse Prevention Period, an expected average of 5 weeks
Secondary outcomes (3)
Hamilton Depression Rating Scale
Reduction on the scores of HDRS (as on the scores of Depression Scale and Hamilton Anxiety Scale; and improves the global clinical status in Clinical Global Impression, Global Assessment Scale and 36-item Short-form Health Survey - Quality of Life)
Measured: baseline and 15 months
Illness severity change
Illness severity change as measured by Clinical Global Impression of Severity for depression.
Measured: baseline and 15 months
subject functioning
Change in subject functioning using the Personal and Social Performance Scale (PSP)
Measured: baseline and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study start1 Jan 2013
- Primary completion30 Dec 2016
- Study completion25 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- rTMS intervention
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The No.3 hospital of PLA, The No.91 hospital of PLA, No. 102 Hospital of Chinese People's Liberation Army
- Responsible party
- Principal investigator, Huaning Wang, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516931
- Sponsor's protocol ID
- Huaning Wang
- Other IDs
- XijingH
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2011
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang H, Xue Y, Chen Y, Zhang R, Wang H, Zhang Y, Gan J, Zhang L, Tan Q. Efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of depression: study protocol for a randomized controlled trial. Trials. 2013 Oct 17;14:338. doi: 10.1186/1745-6215-14-338.
PubMed 24135054
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Depression.
- ClinicalTrials.gov ID
- NCT01516931
- Acronym / sponsor ID
- Huaning Wang
- Conditions
- Depression
- Keywords
- repetitive Transcranial Magnetic Stimulation (rTMS), Depression, Venlafaxine, Relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- The No.3 hospital of PLA, The No.91 hospital of PLA, No. 102 Hospital of Chinese People's Liberation Army
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 25 Feb 2017 (actual)
- First posted
- 25 Jan 2012 (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 purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale.
Detailed description
Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of depression.Depression is a chronic illness and generally requires life-long treatment. However, up to current days there have been no studies evaluating the effects of rTMS in the maintenance treatment of depression. This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of rTMS, as monotherapy, relative to placebo in delaying the time to relapse in patients with depression. Patients with acute symptoms of depression will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose stabilization period, and a 12 months double-blind relapse prevention period. The study will consist of 4 phases: a screening/tolerability phase of up to 7 days; an open-label, flexible-dose lead-in phase of 8 weeks; an open-label, fixed-dose stabilization phase of 6 weeks; and a single-blind relapse prevention phase of 12 months. During the open-label phase, all patients will be treated with venlafaxine. Remitterswith Hamilton Rating Scale for Depression [HAM-D17] score ≤ 7will be eligible to enter the single-blind phase and will be randomly assigned to one of three groups: group 1 on active rTMS and venlafaxine; group 2 on sham rTMS and venlafaxine; group 3 on venlafaxine alone. Efficacy will be evaluated during the study using relapse assessment (time between subject randomization to treatment and the first occurrence of relapse). Secondary outcome measures will include: symptom changes, measured by the Hamilton Rating Scale for Depression [HAM-D17]; illness severity changes, measured by the Clinical Global Impression of Severity for Depression (CGI-S-DEP); and changes in subject functioning, assessed with the Personal and Social Performance Scale. Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiography, and measurements of vital signs (temperature, pulse and blood pressure) and weight. Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- rTMS intervention
| Arm | Type | Receives |
|---|---|---|
| active rTMS and venlafaxine | Experimental | Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)rTMS：Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months. venlafaxine：150-225mg/day |
| sham rTMS and venlafaxine | Placebo comparator | Behavioral: counselingSham stimulation will be given at the same site and frequency, using a Magstim sham-coil system. During rTMS, participants will be instructed to keep their eyes open and relax. |
| venlafaxine alone | Placebo comparator | Behavioral: counselingresponders will be maintained on the same effective dose of venlafaxine for the entire duration of the RCT, unless they relapse and will have to exit the protocol and enter a naturalistic follow-up |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of depression
- Experiencing an acute exacerbation of depression symptoms
- Baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items
- Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
Key exclusion criteria (10 listed)
- Comprised ferromagnetic metallic implants
- Pacemakers
- Previous neurosurgery
- History of seizures
- Major head trauma
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)1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks | Procedure or surgery | active rTMS and venlafaxine |
| counselingPlacebo monthly by general counseling for 12 months. | Behavioural | sham rTMS and venlafaxine, venlafaxine alone |
Primary outcome
Time for relapse
Time frame: Participants will be followed for the duration of 15 month double-blind Relapse Prevention Period, an expected average of 5 weeks
Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period
3 secondary outcomes
Hamilton Depression Rating Scale
Time frame: baseline and 15 months
Illness severity change
Time frame: baseline and 15 months
subject functioning
Time frame: baseline and 15 months
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 13 Jan 2020.
- Derived from this study: PubMed 24135054Wang H, Xue Y, Chen Y, Zhang R, Wang H, Zhang Y, Gan J, Zhang L, Tan Q. Efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of depression: study protocol for a randomized controlled trial. Trials. 2013 Oct 17;14:338. doi: 10.1186/1745-6215-14-338.
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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 study testing repetitive Transcranial Magnetic Stimulation (rTMS) and counseling in people with Depression, run by Xijing Hospital at 1 site in China.
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 10 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 13 Jan 2020. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Time for relapse (time frame: Participants will be followed for the duration of 15 month double-blind Relapse Prevention Period, an expected average of 5 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 NCT01516931, which also lists 1 linked publication.
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 13 Jan 2020.