Single I.V.-ketamine Augmentation of Newly Initiated Venlafaxine Hydrocortisone for Treatment-resistant Depression: Randomized, Double-blind Controlled Study Protocol
Yun Du, Ruobing Feng, Wenle Zhang, Jiexin Fang, Ke Ma, Encong Wang, Yongdong Hu
preprint DOI: 10.21203/rs.3.rs-1244643/v1 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Clinical protocol Randomized Double-blind |
|---|---|
| Sample size | 32 |
| Population | Patients with treatment-resistant depression |
| Interventions | Ketamine Venlafaxine hydrochloride Midazolam maleate |
| Dose | ketamine 0.5 mg/kg over 40 min; midazolam maleate 0.045 mg/kg over 40 min |
| Duration | 4-week double-blind treatment; assessments at baseline, 1, 2, 4, 24, 48, 72 hours and 7, 14, 21, 28 days |
| Measures | Montgomery–Asberg Depression Rating Scale (MADRS), 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16), Brief Psychiatric Rating Scale-4 (BPRS-4), Young Manic Rating Scale (YMRS), Clinician-Administered Dissociative States Scale (CADSS), Frequency and Intensity of Side Effects Rating/Global Rating of Side Effects Burden (FISER/GRSEB), Patient Rated Inventory of Side Effects (PRISE) |
| Topics | Depression Esketamine Ketamine |
| Key points | The protocol proposes testing whether a single intravenous ketamine infusion combined with four weeks of venlafaxine hydrochloride can rapidly relieve depressive symptoms and improve remission rates in treatment-resistant depression, compared with midazolam plus venlafaxine. No results are reported; the authors state the trial will provide information on this combined intervention's efficacy and safety. |
Abstract
Abstract 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 decay rapidly and repeated dosing increases the risks. This study aimed to explore the efficacy and safety of single intravenous ketamine, combined with venlafaxines 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.