Depression
Conditions
Keywords
depression, transcranial direct current stimulation, direct current stimulation, tdcs
Brief summary
The purpose of this study is to see if transcranial direct current stimulation may improve the symptoms of depression.
Detailed description
The purpose of this study is to learn about a brain stimulating procedure called transcranial direct current stimulation (tDCS). In tDCS therapy, two moistened sponges are applied to the forehead while a small amount of electric current flows between them. These electrodes are placed on the head so that the electricity will pass through a region in the brain that is believed to contribute to depression. This study is intended to test the theory that the electromagnetic field created by the current may affect this region of the brain in a way that may improve the symptoms of depression. This may affect brain activity and function.
Interventions
DEVICEtranscranial direct current stimulation
Two damp sponges, one placed on the left side of the forehead, the other on the left arm. 0.1mA of current is passed for 20 minutes.
DEVICEiomed phoresor transcranial direct current stimulation
for the sham group the current is turned off after 10 seconds
Sponsors
National Alliance for Research on Schizophrenia and Depression
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Has a diagnosis of a major depressive episode or bipolar disorder and is currently in a major depressive episode (without psychotic features) * Total pretreatment HDRS (Hamilton Depression Rating Scale)-24 score \>= 18 (The Hamilton Depression Rating Scale is an interviewer scored tool for assessing the severity of depressive symtoms. The scale ranges from 0 (no symptoms, absence of depression) to 64 Category Ham-24 Score Normal, not depressed 9 or less Mildly depressed 10 to 19 Moderately depressed 20 to 29 Markedly/severely depressed 30 or more) * Capable and willing to provide informed consent
Exclusion criteria
* History of depression previously untreated with medication, bipolar disorder, schizophrenia, schizoaffective disorder (non mood disorder), psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), psychotic features in this or previous episodes, amnestic disorder, dementia or mms\<24, DELIRIUM * Significant current history of autoimmune, endocrine, viral or vascular disorder affecting the brain * History of unstable cardiac disease, uncontrolled hypertension, or sleep apnea * Changes in psychotropic medications within two weeks prior to study entry or patient is unable to maintain stable doses throughout the study trial * Subject has an active suicidal plan and/or attempted suicide in the past twelve months * Patients with a CGI of 6 or greater * Subject is pregnant or has a positive pregnancy serum test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Two weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory II | Two weeks | patient self report of depressive symptoms |
Countries
United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Direct Current Stimulation 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 | 11 |
| Sham tDCS 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. | 8 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Sham tDCS | Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 11 Participants | 19 Participants |
| Age Continuous | 45 years STANDARD_DEVIATION 2 | 45 years STANDARD_DEVIATION 2 | 45 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 8 participants | 11 participants | 19 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 19 | 0 / 8 |
| serious Total, serious adverse events | 0 / 19 | 0 / 8 |
Outcome results
Primary
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).
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
Population: 20 patients were enrolled in the study and 17 patients completed it. The 17 patients who completed the study are the population analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transcranial Direct Current Stimulation | 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). | 2 participants |
| Sham tDCS | 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). | 2 participants |
Secondary
Beck Depression Inventory II
patient self report of depressive symptoms
Time frame: Two weeks
Population: Data for the secondary outcome measure was incompletely collected and not analyzed.