Major Depression Clinical Trial
Official title:
The Effect of Transcranial Direct Current Stimulation (tDCS) on Cognitive Control and Emotion Regulation in Depressed Patients
Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies (ERS) are both central characteristics of major depression. Both are associated with reduced activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. The goal of this randomized, sham-controlled, double blind clinical trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC and ERS in depressed patients compared to healthy subjects. Overall, the study will include 44 participants (22 depressed Patients and 22 healthy subjects). Each participant will complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting phase by means of a questionnaire and psychophysiological measures (heart rate variability). The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this experiment will provide new and reliable data for the development of new treatment methods.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria for depressed patients - diagnosed major depression (DSM-V) - stable medication for four weeks Inclusion Criteria for all participants - right handedness Exclusion Criteria: - history of seizures - metal device throughout the body - pregnancy - use of von antipsychotics / mood stabilizer - diagnosed bipolar disorder - current substance abuse (nicotine excluded) - diagnosed psychotic diseases - diagnosed anorexia nervosa - diagnosed personality disorders: cluster A, antisocial personality disorder, borderline personality disorder Exclusion Criteria for healthy participants: - history of affective disorders or current affective disorder |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Tuebingen | Tubingen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | German Federal Ministry of Education and Research, Universität Tübingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Interstimulusintervall and number of correct trials in the PASAT | To measure the performance in the PASAT the number of correct trials as well as the mean Interstimulusintervall will be assessed. | Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days. | |
Primary | Change of positive and negative affect | Change of positive and negative affect after, compared to before performing the PASAT and also change of the affect during the resting phase. | The positive and negative affect is assessed (a) right before and after the PASAT in two sessions through study completion, on average 10 days. And (b) also after the resting phase in two sessions through study completion, on average 10 days. | |
Primary | Heart rate variability | The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect. | in two sessions through study completion, on average 10 days | |
Primary | Score in state rumination questionnaire | The state rumination will be measured after the resting phase | in two sessions through study completion, on average 10 days |
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