Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder...
Major Depressive DisorderThis is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With...
Depressive DisorderMajor1 moreThe purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive...
Major Depressive DisorderThe purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).
Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients...
Major Depressive DisorderThe study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.
VR-Moodboost; an Innovative Virtual Reality Treatment for Adolescents With Depression
Major Depressive DisorderMajor depressive disorder (MDD) is a prevalent and disabling mental health condition. A recent meta-analysis shows that across all forms of psychotherapy, only 43% of all depressive patients fully recover from MDD and relapse rates are high. Therefore, there is a strong need for innovative interventions with better treatment outcomes. Most traditional psychotherapies for depression focus on reducing negative affect. However, in patients suffering from depression, anhedonia, or loss of positive affect, is associated with poor prognosis and increased chance of suicide. Recent studies show promising results for novel psychotherapies with a focus on enhancing positive affect. Experimental studies indicate that non-verbal stimuli have a stronger impact on activation of positive affect than verbal stimuli, which makes Virtual reality (VR) a promising tool to enhance positive affect. For the current study the investigators developed an innovative VR treatment protocol to enhance positive affect and reduce depressive symptoms in patients with MDD. This study will include 10 adolescents aged 15 to 23 years old, who have a diagnosis of unipolar mild to severe depression. A trained psychologist will perform the VR-Moodboost intervention in twelve weekly sessions. The overall aim of this explorative proof-of-concept study is to provide first evidence that treatment with VR-Moodboost will lead to symptom improvement in adolescents with depression. The investigators hypothesize that VR-Moodboost will lead to an increase in positive affect, daily positive mood and a decrease in negative affect and daily negative mood in adolescents with mild to severe depression. Secondary, the investigators hypothesize that the VR-moodboost will lead to a decrease of depressive symptoms, an increase in daily activation, an increase in quality of life and an increase of self-efficacy for the participating patients. Moreover, the investigators hypothesize that VR-Moodboost leads to high patient acceptability and high usability for both patient and therapist.
Microbiotherapy in Characterized Depressive Disorder
DepressionDepressive Disorder2 moreThe study aims to evaluate the contribution of a multi-targeted microbiotherapy at 12 weeks in depressed-patients in a situation of failure of a 1st line of antidepressant treatment and treated in add-on with a 2nd antidepressant, venlafaxine.
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia
Major Depressive Disorder With InsomniaThis will be a single center, prospective, open label, quasi-experimental pre-post intervention trial in major depressive disorder (MDD) patients with insomnia. The main objectives are i. to assess efficacy of mirtazapine in reducing depression and insomnia symptom severity in major depressive disorder (MDD) patients with insomnia. ii. to evaluate side effects of mirtazapine. Following enrollment and baseline assessment patients will be prescribed mirtazapine at 15-30 mg/day. Depending on the response, doses will be adjusted after two weeks and might be titrated up to 45 mg/day. Each patient will be monitored for 42 days and assessment will be carried out on Day 0, Day 14, Day 28 and Day 42 of the trial.
Self-guided Treatment for Depression
Major Depressive DisorderThis study will examine the efficacy and safety of a self-guided digital therapeutic app for the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents and adults.
Study to Evaluate the Effects of Oral NMRA 335140 Versus Placebo in Participants With Major Depressive...
Major Depressive DisorderThis is a randomized, double blind, placebo controlled, multicenter study to evaluate the effects of NMRA 335140 (formerly BTRX 335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 28 days), and a 6-week Treatment Period (during which participants will receive either NMRA 335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an extension study (NMRA 335140 501).
Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)
Major Depressive DisorderMDD1 moreXanamem is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). This XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamem™ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamem™ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.