Neurologische Störungen

Single I.V.-ketamine Augmentation of Newly Initiated Venlafaxine Hydrocortisone for Treatment Resistant Depression: Randomized, Double blind Controlled Study Protocol

Abstract

Yun Du, Ruobing Feng, Wenle Zhang, Jiexin Fang, Ke Ma, Encong Wang and Yongdong Hu*

Background: The critical issue of treating Treatment Resistant Depression (TRD) is to improve antidepressant effect rapid onset and the recovery rates. Significant antidepressant effects of ketamine onset rapidly, but decays rapidly and repeated dosing increases the risks. This study aimed to explore the efficacy and safety of single intravenous ketamine, combined with venlafaxine’s hydrochloride for TRD.

Methods: 32 patients with treatment resistant depression will be randomly selected to undergo a four weeks double blind treatment with single dose ketamine (0.5 mg/kg over 40 min) and venlafaxine hydrochloride (4 weeks) or midazolam maleate (0.045 mg/kg over 40 min) and venlafaxine hydrochloride (4 weeks). Depressive symptoms will be measured by the Montgomery–Asberg Depression Rating Scale (MADRS) and the 16 item Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16). Adverse effects will be measured by the Brief Psychiatric Rating Scale-4 (BPRS-4), Young Manic Rating Scale (YMRS), the Clinician Administered Dissociative States Scale (CADSS), Frequency and Intensity of Side Effects Rating/Global Rating of Side Effects Burden (FISER/GRSEB) and Patient Rated Inventory of Side Effects (PRISE). Patients will be assessed at baseline, after intervention 1, 2, 4, 24, 48, 72 hours and 7, 14, 21 and 28 days.

Discussion: This study will provide important information on whether this new combined intervention can rapidly relieve the symptoms of depression and improve the remission rates of treatment resistant depression.