Phase 2
N=21
Treating Depression With Transcranial Direct Current Stimulation (tDCS)
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00481988 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: 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). — 2; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- transcranial direct current stimulation (Device); iomed phoresor transcranial direct current stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
2; 2 | — |
| SECONDARY Beck Depression Inventory II |
— | — |
Summary
The purpose of this study is to see if transcranial direct current stimulation may improve the symptoms of depression.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00481988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.