The Effectiveness of rTMS in Depressed VA Patients
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|ClinicalTrials.gov Identifier: NCT01191333|
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : February 7, 2018
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: rTMS Device: Sham Device||Not Applicable|
Major depression occurs in about 10% of American outpatients every year and of those, approximately 20% respond incompletely or not at all to trials of antidepressants, mood stabilizers, or psychotherapy (Kaplan and Sadock, 1996; Keller et al 1992; Thase, 2004). Treatment as usual for these cases of treatment resistant major depression (TRMD) frequently involves increased risks and increased side effects, such as those seen in monoamine oxidase inhibitors (MAOIs) and electroconvulsive therapy (ECT). New TRMD treatments are needed, preferably without major safety concerns or side effects as seen with aggressive polypharmacy or ECT.
Repetitive transcranial magnetic stimulation (rTMS) is a method of delivering brain stimulation without the seizures or risks associated with ECT, nor the potential side effects and risks of MAOI therapy. Systematic review and meta-analysis of the studies to date, which are typically of a small scale, appear to show a positive effect in TRMD (Martin et al. 2003). With a minimal side effect profile, and the rarity of untoward events and side-effects (Pascual-Leone et al. 1993; Wassermann 1997), safety concerns regarding the use of rTMS are considerably less than with ECT. Given this, rTMS has the potential to be a significant advance in care, if it were shown to be effective in TRMD in VA patients.
The trials of rTMS performed to date have not included participants with comorbid disorders, such as substance abuse and post-traumatic stress disorder (PTSD), thus the generalizability of their findings to a VA population is not clear. Further research including Veterans with possible comorbid disorders is necessary, given the high rates of co-occurring substance abuse and PTSD that is present in the Veteran population.
The present study is a randomized, controlled trial that compares active rTMS to a sham condition in Veterans with treatment resistant major depression and possible comorbid post-traumatic stress disorder (PTSD) and / or a history of substance abuse. Veterans will remain under the care of their VA primary mental health provider throughout the project. Participants will be assessed at pre-, mid- and several post-treatment time points. This is a multisite trial that will be conducted at 9 VA Medical Centers around the country.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||CSP #556 - The Effectiveness of rTMS in Depressed VA Patients|
|Actual Study Start Date :||July 2, 2012|
|Actual Primary Completion Date :||February 15, 2017|
|Actual Study Completion Date :||March 31, 2017|
Experimental: Active rTMS
Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.
Repetitive Transcranial Magnetic Stimulation
Placebo Comparator: Sham rTMS
Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel.
Device: Sham Device
Placebo Device that simulates active rTMS treatment
- The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression [ Time Frame: End of acute treatment 4-6 weeks ]The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.
- Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS) [ Time Frame: End of acute treatment 4-6 weeks, then end of F/U 6 months ]To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.
- Mean Depression Score as Assessed by Beck Depression Inventory (BDI) [ Time Frame: Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months ]This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state.
- Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS) [ Time Frame: End of acute treatment 4-6 weeks, then end of F/U 6 months ]The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.
- Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS) [ Time Frame: End of acute treatment 4-6 weeks, then end of F/U 6 months ]The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.
- Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: End of acute treatment 4-6 weeks, then end of F/U 6 months ]As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). A high score represents a worse outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191333
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA|
|Palo Alto, California, United States, 94304-1290|
|San Francisco VA Medical Center, San Francisco, CA|
|San Francisco, California, United States, 94121|
|United States, Ohio|
|Cincinnati VA Medical Center, Cincinnati, OH|
|Cincinnati, Ohio, United States, 45220|
|United States, Pennsylvania|
|Philadelphia VA Medical Center, Philadelphia, PA|
|Philadelphia, Pennsylvania, United States, 19104|
|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|
|Pittsburgh, Pennsylvania, United States, 15240|
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center, Charleston, SC|
|Charleston, South Carolina, United States, 29401-5799|
|United States, Texas|
|Central Texas Veterans Health Care System, Temple, TX|
|Temple, Texas, United States, 76504|
|United States, Utah|
|VA Salt Lake City Health Care System, Salt Lake City, UT|
|Salt Lake City, Utah, United States, 84148|
|United States, Vermont|
|White River Junction VA Medical Center, White River Junction, VT|
|White River Junction, Vermont, United States, 05009-0001|
|Study Chair:||Jerome A. Yesavage, MD||VA Palo Alto Health Care System, Palo Alto, CA|