Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02141776
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2014-05-15
Brief Title:
Comparison of Anodal Transcranial Direct Current Stimulation t-DCS and Sham Stimulation in Patients With Treatment-resistant Depression
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
A Randomized Blinded Comparison of Anodal Transcranial Direct Current Stimulation t-DCS and Sham Stimulation of Left Prefrontal Cortex in Patients With Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Major depressive disorder MDD is a significant public health problem Existing treatment modalities are not always sufficient to alleviate this disorder Treatment refractoriness is a common clinical problem Transcranial direct current stimulation t-DCS a non-invasive brain stimulation technique has been shown to be effective in alleviating depressive symptoms in preliminary studies There is need to explore the role of t-DCS in Treatment-resistant depression TRD Therefore the investigators aim to undertake this exploratory study
Aim
Compare the role of left prefrontal cortex anodal t-DCS daily stimulation of 4 weeks 20 week days with sham stimulation in alleviating depressive symptoms in patients with TRD
Methodology Patients who seek treatment in our treatment resistant depression clinic and who have failed to respond to treatment with two antidepressant medications will be offered to enroll in this study The aim is to study 20 patients who meet the Diagnostic and Statistical Manual of Mental Disorders 4th Edition DSM-IV criteria for MDD between the ages of 21-65 years Those subjects that receive sham stimulation will be offered to have active t-DCS stimulation for additional 3 weeks to get any benefit that they may have otherwise missed by being in the sham stimulation group
Results and Conclusions The investigators will compare the mean baseline and end of treatment Montgomery Asberg depression rating scale between the two groups The investigators will compare the change in mean depression scores between the baseline and end of treatment in those receiving active t-DCS for a total of 7 weeks duration This study is innovative and of significance in exploring the role of this novel easy to administer safe and cost effective treatment modality
Aim
Compare the role of left prefrontal cortex anodal t-DCS daily stimulation of 4 weeks 20 week days with sham stimulation in alleviating depressive symptoms in patients with TRD
Methodology Patients who seek treatment in our treatment resistant depression clinic and who have failed to respond to treatment with two antidepressant medications will be offered to enroll in this study The aim is to study 20 patients who meet the Diagnostic and Statistical Manual of Mental Disorders 4th Edition DSM-IV criteria for MDD between the ages of 21-65 years Those subjects that receive sham stimulation will be offered to have active t-DCS stimulation for additional 3 weeks to get any benefit that they may have otherwise missed by being in the sham stimulation group
Results and Conclusions The investigators will compare the mean baseline and end of treatment Montgomery Asberg depression rating scale between the two groups The investigators will compare the change in mean depression scores between the baseline and end of treatment in those receiving active t-DCS for a total of 7 weeks duration This study is innovative and of significance in exploring the role of this novel easy to administer safe and cost effective treatment modality
Detailed Description:
Research Plan
1 Patients who score 10 on our intake screening questionnaire the patient Health Questionnaire PHQ-9 will be advised to call to seek participation in this study
2 Patients who seek treatment in our treatment resistant depression clinic will be offered to enroll in this study
3 Patients who have failed to respond to at least two antidepressants in adequate dosage for at least 4 weeks
4 The aim is to have 20 patients complete the study by enrolling 24 patients and screening another 26 patients who meet the diagnostic and statistical manual DSM-IV criteria for Major depressive disorder MDD and have failed treatment with at least two antidepressant medications
5 Patients will be interviewed by investigators to see if they meet the eligibility for inclusion in the study The evaluation will consist a medical and psychiatric evaluation if not done in last one year and a monthly urine pregnancy test for women of child bearing potential If the subjects do not meet the eligibility criteria they will continue to receive routine clinical care or referral for appropriate psychiatric care within or outside of our clinicdepartment
6 Stimulation parameters Left prefrontal anodal t-DCS stimulation daily for four weeks The stimulation parameters current 2 mA continuously for 30 minutes Conductive electrodes covered by sponge soaked in saline will be used The current will gradually be increased to 2mA over 30 seconds to avoid sensation of a flash
7 Patients will be allotted to receive either active or sham stimulation by using a random numbers assignment wwwrandomizerorg Co-investigator Dr Holbert will be doing the assessments rating the depressive symptoms and he kept blind as to the type of stimulation received The same machine will be used to give both active and sham stimulation
8 At the end of four weeks subjects will be offered to stay in open label extension of this study with active left prefrontal anodal t-DCS for another three weeks to receive any benefits they may otherwise not receive by being in sham stimulation
9 Materials Montgomery Asberg depression rating scale MADRS Patient Health Questionnaire PHQ-9 Clinical Global ImpressionCGI at baseline and weekly Improvement will be considered as 50 reduction in depressive scores and remission as a score of less than 9 on MADRS MADRS is a 10 item examiner rated scale that rates various depressive signs and symptoms and has been used extensively in research of brain stimulation techniquesPHQ-9 is a 9 item self-rated questionnaire about depressive symptoms and has been found reliable in studies of depression in primary care and psychiatric settings CGI is a clinician rated impression about treatment response
Procedure outline
Baseline diagnostic interview evaluation of inclusion and exclusion criteria urine pregnancy test if indicated at baseline and day 31 filling in questionnaires PHQ-9 MADRS CGI Daily t-DCS stimulation for 30 minutes patients will be asked about any discomfortside effects
Days 7142128354249 PHQ-9 MADRS CGI
Specifically the investigators will compare baseline to post treatment depression scores via a two-sample t-test comparing active treatment to sham using a two-sided P-value 005 to declare significance The change in MADRS score MADRS will be the primary outcome variables Secondary variables will be analyzed similarly in this pilot study Significant findings on secondary variables will not be considered as definitive
1 Patients who score 10 on our intake screening questionnaire the patient Health Questionnaire PHQ-9 will be advised to call to seek participation in this study
2 Patients who seek treatment in our treatment resistant depression clinic will be offered to enroll in this study
3 Patients who have failed to respond to at least two antidepressants in adequate dosage for at least 4 weeks
4 The aim is to have 20 patients complete the study by enrolling 24 patients and screening another 26 patients who meet the diagnostic and statistical manual DSM-IV criteria for Major depressive disorder MDD and have failed treatment with at least two antidepressant medications
5 Patients will be interviewed by investigators to see if they meet the eligibility for inclusion in the study The evaluation will consist a medical and psychiatric evaluation if not done in last one year and a monthly urine pregnancy test for women of child bearing potential If the subjects do not meet the eligibility criteria they will continue to receive routine clinical care or referral for appropriate psychiatric care within or outside of our clinicdepartment
6 Stimulation parameters Left prefrontal anodal t-DCS stimulation daily for four weeks The stimulation parameters current 2 mA continuously for 30 minutes Conductive electrodes covered by sponge soaked in saline will be used The current will gradually be increased to 2mA over 30 seconds to avoid sensation of a flash
7 Patients will be allotted to receive either active or sham stimulation by using a random numbers assignment wwwrandomizerorg Co-investigator Dr Holbert will be doing the assessments rating the depressive symptoms and he kept blind as to the type of stimulation received The same machine will be used to give both active and sham stimulation
8 At the end of four weeks subjects will be offered to stay in open label extension of this study with active left prefrontal anodal t-DCS for another three weeks to receive any benefits they may otherwise not receive by being in sham stimulation
9 Materials Montgomery Asberg depression rating scale MADRS Patient Health Questionnaire PHQ-9 Clinical Global ImpressionCGI at baseline and weekly Improvement will be considered as 50 reduction in depressive scores and remission as a score of less than 9 on MADRS MADRS is a 10 item examiner rated scale that rates various depressive signs and symptoms and has been used extensively in research of brain stimulation techniquesPHQ-9 is a 9 item self-rated questionnaire about depressive symptoms and has been found reliable in studies of depression in primary care and psychiatric settings CGI is a clinician rated impression about treatment response
Procedure outline
Baseline diagnostic interview evaluation of inclusion and exclusion criteria urine pregnancy test if indicated at baseline and day 31 filling in questionnaires PHQ-9 MADRS CGI Daily t-DCS stimulation for 30 minutes patients will be asked about any discomfortside effects
Days 7142128354249 PHQ-9 MADRS CGI
Specifically the investigators will compare baseline to post treatment depression scores via a two-sample t-test comparing active treatment to sham using a two-sided P-value 005 to declare significance The change in MADRS score MADRS will be the primary outcome variables Secondary variables will be analyzed similarly in this pilot study Significant findings on secondary variables will not be considered as definitive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB201501014 | OTHER | University of Florida | None |