Effect of left anodal transcranial direct current stimulation on hypothalamic-pituitary-adrenal axis (HPAA) activity in patients with depressive episodes: a randomized, triple-blind, pilot trial

Not Applicable

• Conditions: F32.1; F32.2; F31.4; Moderate depressive episode; Severe depressive episode without psychotic symptoms; Bipolar affective disorder, current episode severe depression without psychotic symptoms

• Registration Number: DRKS00029994
• Lead Sponsor: Zentralinstitut für Seelische Gesundheit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-09-20
• Study Start: 2022-08-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

To be included in the study participants had to meet the DSM-V criteria, evaluated through SCID-I interviews, for a depressive episode or major depression and sign the informed consent form. The interviews were carried out by Central Institute of Mental Health clinical experts, who were not involved in the study. Included patients had a Hamilton Depression Rating Scale (HDRS) of at least 18 points with baseline stability (i.e., less than 25% improvement one week before the beginning of stimulation). Before starting the study, we checked that the participants had an ECG sinus rhythm. Therapy-naïve status was not an inclusion criterion for this pilot trial so that the study participants could continue their prescribed treatments at the inpatient unit. During the trial medication was not changed but the doses were adjusted slightly if needed. We chose a three-week trial interval (21 days) to try to avoid the occurrence of essential changes in the pharmacological treatment. Finally, patients taking benzodiazepines as a pro re nata (PRN) treatment could participate with doses no greater than 1.5 mg/d of Lorazepam or equivalent, to keep additional pharmacological effects as low as possible. Participants taking sleep inducers such as Zopiclone and Zolpidem as a PRN treatment were not excluded from this pilot trial.

Exclusion Criteria

Patients with psychotic disorders, post-traumatic stress disorders, panic disorders, and borderline personality disorders were excluded from the study. We also excluded females with current pregnancies, participants with a conservatorship or with legal protectors, and patients who could not give their consent because of severe mental illness. Finally, we excluded patients complying with the following criteria: with metal implants or medical devices (e.g., pacemakers), illegal drug and alcohol dependency at the time of the study, acute suicide crisis, medical conditions that alter adrenal functions, use of glucocorticoids, intake of medication that changes the heart rate and its variability (e.g., beta-blockers), arrhythmias of any type, dementia syndrome (DSM-V/ICD-10 criteria), past medical history of severe cranioencephalic trauma, neurological diseases of any kind, severe decompensated medical conditions (e.g., therapy-resistant arterial hypertension, heart insufficiency, respiratory insufficiency), neoplastic diseases of any kind and infectious diseases of any kind.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this pilot study was any change in the DCP from the baseline to week 3 (W3) in the tDCS group compared with the control group. Additionally, with the data on the DCPs, the area under the curve concerning the ground (AUCg) was calculated using the formulae of Pruessner and colleagues.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes included any change in the CAR from the baseline to W3, any change in the cortisol morning decrease from the baseline to W3, and any change in stimulation-related cortisol levels between W0 and W2.