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Treating Depression With Transcranial Direct Current Stimulation (tDCS)

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ClinicalTrials.gov Identifier: NCT00481988
Recruitment Status : Completed
First Posted : June 4, 2007
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Depression
Interventions Device: transcranial direct current stimulation
Device: iomed phoresor transcranial direct current stimulation
Enrollment 20
Recruitment Details Dates of recruitment period: 2006-2009 Location: community Approved sample size: 23 Total number of participants enrolled: 19
Pre-assignment Details One patient was dropped by the investigator when he had a Hamilton Depression Rating Scale (HDRS) of 8 prior to baseline ratings (DRSS 20 is the minimum for inclusion in the study).
Arm/Group Title Iomed II Phoresor Transcranial Direct Current Stimulation Sham Iomed II Phoresor Transcranial Direct Current Stimulation
Hide Arm/Group Description The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation. The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
Period Title: Overall Study
Started 12 9 [1]
Crossover 11 [2] 8 [3]
Completed 11 8
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
[1]
one patient was dropped from the study before randomization
[2]
patient dropped out of study after 5 sessions to pursue other treatment options
[3]
patient dropped out of study after 5 sessions to illness unrelated to study
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS Total
Hide Arm/Group Description one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session. Total of all reporting groups
Overall Number of Baseline Participants 11 8 19
Hide Baseline Analysis Population Description
One patient dropped out of study after 5 treatments due to One patient dropped out of study after 5 treatments to pursue other treatment options One patient dropped by investigator when patient had HDRS of 8 at baseline ratings One patient dropped out of study after 1 treatment to pursue other treatment options
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 8 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
8
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 8 participants 19 participants
45  (2) 45  (2) 45  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 8 participants 19 participants
Female
4
  36.4%
3
  37.5%
7
  36.8%
Male
7
  63.6%
5
  62.5%
12
  63.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 8 participants 19 participants
11 8 19
1.Primary Outcome
Title Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression).
Hide Description The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS < 10 for 2 weeks.
Time Frame Two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
20 patients were enrolled in the study and 17 patients completed it. The 17 patients who completed the study are the population analyzed.
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS
Hide Arm/Group Description:
one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
Overall Number of Participants Analyzed 9 8
Measure Type: Number
Unit of Measure: participants
2 2
2.Secondary Outcome
Title Beck Depression Inventory II
Hide Description patient self report of depressive symptoms
Time Frame Two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data for the secondary outcome measure was incompletely collected and not analyzed.
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS
Hide Arm/Group Description:
one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS
Hide Arm/Group Description one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
All-Cause Mortality
Transcranial Direct Current Stimulation Sham tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transcranial Direct Current Stimulation Sham tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Transcranial Direct Current Stimulation Sham tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/19 (10.53%)      0/8 (0.00%)    
Injury, poisoning and procedural complications     
scalp burn * 1 [1]  2/19 (10.53%)  2 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, other
[1]
two of the participants suffered scalp burns under the site of the sponge electrode. These were similar to sunburns and resolved completely by the next day. These burns occurred only in subjects receiving active tDCS, not sham tDCS.
Data for the secondary outcome measure (Beck Depression Inventory) was incompletely collected and not analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter Bulow MD, Assistant Professor of Clinical Psychiatry
Organization: Division of Experimental Therapeutics, NY State Psychiatric Organization
Phone: (212) 543 5664
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00481988     History of Changes
Other Study ID Numbers: 5405
First Submitted: June 1, 2007
First Posted: June 4, 2007
Results First Submitted: December 6, 2012
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013