Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Depression
Condition: Depression
MeSH terms: Recurrence; Depression; Depressive Disorder
Study type: Interventional

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. 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.
    

Intervention name(s): repetitive Transcranial Magnetic Stimulation (rTMS); counseling
Intervention type(s): Procedure; Behavioral
Intervention description(s): 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks; Placebo monthly by general counseling for 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: rTMS intervention
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: repetitive Transcranial Magnetic Stimulation (rTMS); Depression; Venlafaxine; Relapse