Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression
NCT00714090
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- 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)
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression | |||
Official Title ICMJE | Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study. | |||
Brief 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. | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Unipolar Depression | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 170 | |||
Original Estimated Enrollment ICMJE | 363 | |||
Actual Study Completion Date ICMJE | July 2013 | |||
Actual Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France, Monaco | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00714090 | |||
Other Study ID Numbers ICMJE | SAD-001 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Dr Emmanuel POULET, Club rTMS et Psychiatrie | |||
Study Sponsor ICMJE | Club rTMS et Psychiatrie | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Club rTMS et Psychiatrie | |||
Verification Date | July 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |