Unipolar DepressionPhase 3NCT00714090
Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression
A Phase 3 study testing active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed in people with Unipolar Depression, run by Club rTMS et Psychiatrie at 18 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 18 sitesin 2 countries
- Study dates
- May 2008to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- 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
- I or II bipolar disorder
- 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
18 sites in 2 countries.
18 sites in 2 countries
France17 sites
C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
Besançon, 25000
C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
Bron, 69500
C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
Clermont-Ferrand, 63000
Hôpital Louis Mourier
Colombes, 92700
C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
Dijon, 21000
C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
Grenoble, 38000
ASM Limoux
Lézignan-Corbières, 11200
Hôpital Fontan - C.H.R.U. Lille
Lille, 59000
C.H. Sainte Marguerite
Marseille, 13000
CHU - Hôpital La Colombière
Montpellier, 34000
Hôpital Pasteur - CHU Nice
Nice, 06000
Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
Paris, 75014
C.H.U. de POITIERS
Poitiers, 86000
C.H.U. - C.H. Guillaume Régnier
Rennes, 35000
C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
Rouen, 76000
EPS de Ville Evrard - Unité de Saint-Denis
Saint-Denis, 93200
CHU St Etienne - Hôpital Nord
Saint-Etienne, 42055
About this study
Official title: Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.
Read the detailed description
rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.
- Conditions
- Unipolar Depression
- Being tested
- active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed, active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine, sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine
- Keywords
- repetitive Transcranial Magnetic Stimulation (rTMS), Major depressive disorders, Depression, Venlafaxine
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine BiomedOther
Also called venlafaxine, Wyeth, repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomed
active venlafaxine LP 75 mg : 1 capsule 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 : 5 sessions per week for 2 to 6 weeks
active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxineOther
Also called repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomed, venlafaxine, Wyeth
active rTMS : 5 sessions per week for 2 to 6 weeks sham venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks.
sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxineOther
Also called repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomed, venlafaxine, Wyeth
sham rTMS : 5 sessions per week for 2 to 6 weeks active venlafaxine LP 75 mg : 1 capsule 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 |
|---|---|---|
| A | Active comparator | Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week) Receives: Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed |
| B | Experimental | active rTMS (5 times/week) and sham venlafaxine (150 mg/day) Receives: Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine |
| C | Sham comparator | sham rTMS (5 times/week) and active venlafaxine (150 mg/day) Receives: Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed 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)and Montgomery Asberg Depression Rating Scale (MADRS)
Measured: 2 to 6 weeks
Secondary outcomes (5)
Onset of action for remission and response (HDRS-17 diminution > 50%)
Measured: 2 to 6 weeks
Anxiety will be assessed using the Covi Anxiety Scale.
Measured: 2 to 6 weeks
Side effects will be assessed using the UKU Scale.
Measured: 2 to 6 weeks
Evaluation of depression using 2 other scales : the Montgomery Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory scale (BDI-13)
Measured: 2 to 6 weeks
Onset of action using the Clinical Global Impressions scale (CGI)
Measured: 2 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2012
- Study completionJul 2013
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 Unipolar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Club rTMS et Psychiatrie
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Dr Emmanuel POULET, Club rTMS et Psychiatrie
- Investigators
- Emmanuel POULET, MD, PhD, Principal investigator, EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714090
- Sponsor's protocol ID
- SAD-001
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2008
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.
PubMed 25192980
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
- ClinicalTrials.gov ID
- NCT00714090
- Acronym / sponsor ID
- SAD-001
- Conditions
- Unipolar Depression
- Keywords
- repetitive Transcranial Magnetic Stimulation (rTMS), Major depressive disorders, Depression, Venlafaxine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Club rTMS et PsychiatrieUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- May 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Jul 2008 (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 assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.
Detailed description
rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine BiomedDouble active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week) |
| B | Experimental | Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxineactive rTMS (5 times/week) and sham venlafaxine (150 mg/day) |
| C | Sham comparator | Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxinesham rTMS (5 times/week) and active venlafaxine (150 mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults
- 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 (8 listed)
- I or II bipolar disorder
- Psychotic features
- Failure of one previous venlafaxine treatment
- Addiction comorbidity or schizophrenia comorbidity
- Involuntary hospitalization
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 venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine BiomedAlso: venlafaxine, Wyeth, repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomedactive venlafaxine LP 75 mg : 1 capsule 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 : 5 sessions per week for 2 to 6 weeks | Other | A |
| active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxineAlso: repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomed, venlafaxine, Wyethactive rTMS : 5 sessions per week for 2 to 6 weeks sham venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks. | Other | B |
| sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxineAlso: repetitive transcranial magnetic stimulator, Inomed, repetitive transcranial magnetic stimulator, Alpine Biomed, venlafaxine, Wyethsham rTMS : 5 sessions per week for 2 to 6 weeks active venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks. | Other | C |
Primary outcome
The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: 2 to 6 weeks
5 secondary outcomes
Onset of action for remission and response (HDRS-17 diminution > 50%)
Time frame: 2 to 6 weeks
Anxiety will be assessed using the Covi Anxiety Scale.
Time frame: 2 to 6 weeks
Side effects will be assessed using the UKU Scale.
Time frame: 2 to 6 weeks
Evaluation of depression using 2 other scales : the Montgomery Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory scale (BDI-13)
Time frame: 2 to 6 weeks
Onset of action using the Clinical Global Impressions scale (CGI)
Time frame: 2 to 6 weeks
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 19 Jul 2013.
- Derived from this study: PubMed 25192980Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.
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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.
Emmanuel POULET, MD, PhD principal investigator
EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed in people with Unipolar Depression, run by Club rTMS et Psychiatrie at 18 sites in 2 countries.
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 8 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Monaco. 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?
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?
The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS) (time frame: 2 to 6 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 NCT00714090, 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 19 Jul 2013.