DepressionPhase 3NCT01370304
Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder
A Phase 3 study testing active rTMS and active Venlafaxine in people with Depression, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- active rTMS and active Venlafaxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Dec 2013
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 years and older
- Clinical diagnosis of major depressive disorder (DSM-IV)
- HDRS-17 items > 20
- Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)
Who cannot join
- Psychotic features
- Failure of one previous venlafaxine treatment
- Addiction comorbidity or schizophrenia comorbidity
- Involuntary hospitalization
- Seizures history
- Pregnancy or breastfeeding
- Somatic comorbidity able to impact on cognitive functions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yun chun Chen
Xi'an, Shaanxi, 710032
Yun chun Chen, Ph.D, +086-13720582601, Yunchunchen@163.com
Shufang Feng, Ph.D, +086-13227807801, fangshuan1984@yahoo.com.cn
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
The purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. fMRI will be performed to determine if treatment response is related to changes in fMRI, and use it to investigate the respondence to the treatments.
- Conditions
- Depression
- Being tested
- active rTMS and active Venlafaxine, active rTMS and sham Venlafaxine, sham rTMS and active Venlafaxine
- Keywords
- repetitive Transcranial Magnetic Stimulation (rTMS), Depression, Venlafaxine, fMRI
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMS and active VenlafaxineOther
Also called venlafaxine: Wyeth, rTMS: MagVenture
rTMS parameters : 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
Venlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks
active rTMS and sham VenlafaxineOther
Also called venlafaxine: Wyeth, rTMS: MagVenture
rTMS parameters : 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
sham rTMS and active VenlafaxineOther
Also called venlafaxine: Wyeth, rTMS: MagVenture
rTMS parameters :same coil, same number of pulses but using an angled coil(90 degree)over the frontotemporal region
Venlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| active rTMS and active Venlafaxine | Experimental | Not described Receives: Other: active rTMS and active Venlafaxine |
| active rTMS and sham Venlafaxine | Experimental | Not described Receives: Other: active rTMS and sham Venlafaxine |
| sham rTMS and active Venlafaxine | Sham comparator | Not described Receives: Other: sham rTMS and active Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is remission
It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)
Measured: 1-6 weeks
Secondary outcomes (4)
fMRI
Measured: 0,6 weeks
CGI
Using the Clinical Global Impression scale(CGI)
Measured: 1-6 weeks
QIDS-C30
Measured: 1-6 weeks
UKU Scale
Side effects will be assessed using the UKU Scale
Measured: 1-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fengshufang, Xijing Hospital
- Investigators
- Qingrong Tan, Ph.D, Study chair, Department of Psychiatry, Xi Jing hospital, Xi'an, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370304
- Sponsor's protocol ID
- 20110526-09
- Status last verified
- Feb 2012
- First submitted
- 8 Jun 2011
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) Compared or Associated With Venlafaxine for Depressive Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
- ClinicalTrials.gov ID
- NCT01370304
- Acronym / sponsor ID
- 20110526-09
- Conditions
- Depression
- Keywords
- repetitive Transcranial Magnetic Stimulation (rTMS), Depression, Venlafaxine, fMRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Jun 2011 (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 treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. fMRI will be performed to determine if treatment response is related to changes in fMRI, and use it to investigate the respondence to the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active rTMS and active Venlafaxine | Experimental | Other: active rTMS and active Venlafaxine |
| active rTMS and sham Venlafaxine | Experimental | Other: active rTMS and sham Venlafaxine |
| sham rTMS and active Venlafaxine | Sham comparator | Other: sham rTMS and active Venlafaxine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years and older
- Clinical diagnosis of major depressive disorder (DSM-IV)
- HDRS-17 items > 20
- Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)
Key exclusion criteria (7 listed)
- Psychotic features
- Failure of one previous venlafaxine treatment
- Addiction comorbidity or schizophrenia comorbidity
- Involuntary hospitalization
- Seizures history
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 |
|---|---|---|
| active rTMS and active VenlafaxineAlso: venlafaxine: Wyeth, rTMS: MagVenturerTMS parameters : 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 Venlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks | Other | active rTMS and active Venlafaxine |
| active rTMS and sham VenlafaxineAlso: venlafaxine: Wyeth, rTMS: MagVenturerTMS parameters : 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 | Other | active rTMS and sham Venlafaxine |
| sham rTMS and active VenlafaxineAlso: venlafaxine: Wyeth, rTMS: MagVenturerTMS parameters :same coil, same number of pulses but using an angled coil(90 degree)over the frontotemporal region Venlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks | Other | sham rTMS and active Venlafaxine |
Primary outcome
The primary outcome measure is remission
Time frame: 1-6 weeks
It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)
4 secondary outcomes
fMRI
Time frame: 0,6 weeks
CGI
Time frame: 1-6 weeks
QIDS-C30
Time frame: 1-6 weeks
UKU Scale
Time frame: 1-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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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.
Qingrong Tan, Ph.D study chair
Department of Psychiatry, Xi Jing hospital, Xi'an, China
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 active rTMS and active Venlafaxine 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 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 2012. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunchun Chen, Ph.D (+086-13720582601, Yunchunchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is remission (time frame: 1-6 weeks). 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 15 Feb 2012.