View clinical trials related to Treatment Resistant Depression.
Filter by:The purpose of this study is to see if psilocybin, an investigational drug, is safe and well tolerated. Researchers also want to know if psilocybin can improve symptoms of depression. This study will see if psilocybin is safe and well tolerated by tracking changes in suicidal thoughts and behaviour, monitoring if any participants choose to stop participating in the study, and measuring any serious side effects, as well as how long they take to resolve. This study will also see if depression symptoms improve (or worsen) after psilocybin is administered. Additional information about participants' depressive symptoms and side effects will also be measured during the study.
The purpose of this study is to compare the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) conducted over 16 weeks (acute and continuation treatment) with Behavioral Activation (BA; same dose and duration) in persistently depressed treatment-resistant inpatients regarding efficacy, moderators and mediators of change.
The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode. The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.
A single centre clinical trial to evaluate the feasibility, safety and efficacy of psilocybin, given under supportive conditions, in a randomised, blinded design in adult participants with treatment resistant major depressive disorder. The primary objective is to evaluate feasibility by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS).
The purpose of the study is to investigate a short-term treatment option for major depressive disorders by administering nitrous oxide gas. At this time, the main purpose is to complete a feasibility study with 40 participants suffering from treatment-resistant depression. Participants will be randomized to (1) Study group: Nitrous oxide (inhaled) + solution of saline (injected) and the (2) Control group: Oxygen (inhaled) + Midazolam (injected) as an Active Placebo.
Phase I study of a virtual neuro-navigation package with built-in support for identifying specific "surface-based" targets to optimze TMS treatment.
The present study has been designed to compare the efficacy and safety of augmentation of SSRIs with Amantadine vs Pramipexole vs the recommended Quetiapine augmentation in Treatment-Resistant Depression (TRD) and correlate the changes in depression scores with changes in the serum levels of Brain-derived neurotrophic factor (BDNF) and Nerve growth factor (NGF). The proposed study will be a prospective, randomized, single-blind, controlled clinical trial in patients with TRD and will be conducted over a period of 2 years. The study cohort will comprise 150 patients with unipolar depression clinically diagnosed as TRD, who are currently on Sertraline treatment (dose range = 100-200 mg/day). At baseline, Hamilton Depression Scale (HAM-D 21 item) will be administered to determine the severity of depressive symptoms, Clinical Global Inventory (CGI) will be administered to determine the baseline severity of the illness. Serum BDNF, and NGF will be estimated by ELISA using commercially available Human ELISA kit. The sample will be divided into 3 equal treatment groups by block randomization technique, each group comprising of 50 patients. Group 1 will receive Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment. Group 2 will receive Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment. Group 3 will serve as the control arm and receive the recommended Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment. The study cohort will be reassessed for the changes in HAM-D scores, CGI severity scores, Improvement score and Efficacy index, at 4 and 8 weeks follow up. The changes in Serum BDNF, and NGF will be estimated at the end of 8 weeks, to correlate with the change in severity of depressive symptoms. All the participants will be evaluated for any untoward side effects in a prescribed format for the Pharmacovigilance program of India (PVPI). The patient in either of the treatment arms, who are not responding to treatment or relapsing with aggravation of depressive symptoms will be switched on to Venlafaxine treatment or Electro-convulsive therapy (ECT) as decided by the treating team.
Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.
Treatment-resistant depression (TRD) is a common cause of disability and one of the most common psychiatric disorders worldwide. Electroconvulsive therapy (ECT) is currently the most effective treatment for TRD. Recent developments showed esketamine to be a rapid-acting and effective antidepressant drug and it has been hailed as a breakthrough in treating TRD. Common treatment algorithms for TRD list ECT as a treatment option, but esketamine has not yet found its exact position in those algorithms. To the investigators' knowledge, a longitudinal, randomized controlled trial comparing the efficacy of ECT and intranasal esketamine in TRD patients has not been conducted. Furthermore, the investigators intend to measure effects of ECT and intranasal esketamine on brain connectivity and structure, using functional magnetic resonance imaging (fMRI). In this study, inpatients with TRD at the University Hospital for Psychiatry I, Medical University Innsbruck, will be randomized to ECT or intranasal esketamine. Short- and medium-term treatment effects on functional and structural connectivity in the brain will be determined using fMRI.
This study aims to assess the efficacy and safety of intranasal esketamine as maintenance antidepressant therapy in patients who have demonstrated clinical improvement with off-label intravenous racemic ketamine for treatment-resistant depression.