Active clinical trials for "Depressive Disorder"

Depression and anxiety are among our most common diseases and the prevalence is increasing. When suffering from depression or anxiety, the individual's ability to cope with everyday life occupations is decreased, as well as the ability to relate to others. The Tree Theme Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop strategies for occupations in everyday life and relationships with others. The method involves using creative activities to create a life story focusing on everyday occupations and to create an imagination of future possibilities/goals. The TTM is a short-term therapy with five sessions. The treatment also implies that the patient is asked to identify various homework tasks to perform between the sessions. The aim of the project is to investigate the effects of the TTM compared to a control group for people with depression and anxiety diagnosis. The intention is to examine the effect on outcome measures regarding psychological symptoms, everyday occupations and health. The study has been approved by the Regional Ethical Review Board. The project is a randomized multicenter study with an intervention group and a control group. A total of 130 patients will be included. Inclusion criteria are patients with depression and/or anxiety in the age of 18-65 years and who have problems with their everyday occupations. Exclusion criteria are individuals with a severe somatic illness or psychosis and/or who have difficulties to understand and fill out self-rating questionnaires. The project implies that doctors will refer appropriate patients to the occupational therapist. After informed consent each patient will be drawn to the TTM or control. Before and after the treatment, as well as 3 and 12 months after finished treatment the patient will meet a project assistant in order to respond to questionnaires regarding psychological symptoms, everyday occupations and health. The study is a collaborative project involving the Region Skåne, Kronoberg County Council, and Jönköping County Council. Doctors will recruit patients and occupational therapists will perform the treatment. The research team comprise of researchers from Kronoberg County Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health Sciences in Jönköping (P Wagman).

This pilot study aims to investigate the potential role of transcranial direct current stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD). tDCS is a noninvasive brain stimulation technique which has been utilized for the treatment of major depression in several studies, both as a primary and adjunctive treatment. The treatment will be administered under the supervision of a physician with experience in administering the treatment and monitoring for complications. This will be a prospective "adaptive tDCS stimulation" open label research study. Participants will receive 20 minute sessions of up to 4 milliamps (mA) transcutaneous electrical stimulation sessions over 4 to 6 weeks. Building on the theory that greater current "dose" may be a significant factor in determining efficacy, this study aims to determine whether higher tDCS current doses lead to greater improvements in depressive symptoms in this population of patients with treatment-resistant major depressive disorder.

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant bipolar depression. In this open-label study, all participants will receive accelerated theta-burst stimulation.

Cluster randomized controlled trial to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the prevention of mother-to-child-transmission (PMTCT) care cascade at 8 antenatal care (ANC) clinics in Uganda.

The purpose of this study is to assess the efficacy of seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with an selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with major depressive disorder (MDD) in open-label treatment phase.

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.

PROTOCOL SYNOPSIS Title The effect of psilocybin on Major depressive disorder (MDD) symptom severity and synaptic density - a single dose randomized, double blind, placebo-controlled phase 2b positron emission tomography study Study Code PSIPET Name of Sponsor SLSO Organisationsnr: 232100-0016 Sponsor representative: Andreas Carlborg Norra Stockholms Psykiatri Vårdvägen 3 112 19 Stockholm Sweden Medical Monitor Inspira Medical AB Phase of Study Phase 2b Sample Size 30 randomized Name of Investigational Product (IP) Psilocybin, 3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate Name of Active Placebo Niacin EudraCT 2020-002790-94 Description of IP and Active Placebo PSIPET Protocol 5 200821 Page 14 Study Intervention Name: Psilocybin (active drug product) Niacin (active placebo product) Dosage formulation: One active capsule contains 25 mg of psilocybin One active placebo capsule contains 100 mg of niacin Capsule: Size 2 hydroxypropyl methylcellulose (HPMC), opaque Size 2 HPMC, opaque Unit dose strength: 25 mg 100 mg Route of Administration: Oral (solid dose) Oral (solid dose) Dosing instructions: One capsule administered with water One capsule administered with water Packaging and Labeling: Study Intervention will be provided in a high-density polyethylene (HDPE) bottle. Each bottle will contain one capsule (psilocybin or niacin) and will be labeled as required per Swedish requirement for blinded study.

Public safety personnel (PSP) have regular and often intense exposure to potentially traumatic events at work and are at higher risk for developing mental health problems such as posttraumatic stress disorder (PTSD). Studies have shown up to 4 times higher suicidal ideation, attempt and death among this population compared to the general population. Despite the high rate of mental health problems among PSPs, their willingness to receive mental healthcare support is fairly low, mainly due to the stigma attached to these disorders. Those who are willing to seek help face unique barriers including their irregular shift hours, limiting their access to resources otherwise available to the public. Given these challenges and the critical contribution of PSPs to public safety, developing innovative solutions to address their mental health must be a healthcare priority. This proposal aims to study the efficacy of using an innovative approach in delivering mental health online, to address mental health problems among correctional workers (CW), who are especially prone to mental health problems given the high rate of workplace violence. It is hypothesized that using an online platform to deliver cognitive behavioural therapy (CBT), would lower the stigma of receiving care in a secure and confidential environment, easing CW's concerns about stigma from co-workers. The content is delivered through interactive and engaging therapy modules, designed for specific groups of CWs and customized by situational examples to make therapy more relatable. These online modules would provide CWs with 24/7 access to therapy content, solving the irregular work hour problem. The online CBT modules developed in this study would provide high quality and clinically validated resources to address mental health problems of CWs all across Canada. Knowledge acquired through this project could also be beneficial to using iCBT in general for addressing mental health challenges among other PSPs.

Mothers and birthing parents (hereafter referred to as mothers) who have recovered from Postpartum Depression and are well now, receive training to teach a 9 week Cognitive Behavioural Therapy (CBT) treatment to mothers who are feeling depressed after giving birth in the last year. Eligible mothers are randomly assigned to one of two groups. Mothers in one group will receive a 9 week group CBT intervention delivered online by the trained Peer facilitators. Mothers in the other group will not receive the CBT group intervention and will continue to receive treatment as usual or regular care for new mothers. Mothers in both groups will complete online questionnaires three times - when participants start the study, nine weeks later and six months after that. Mothers in the intervention group will also complete a few questionnaires once during the intervention and a satisfaction questionnaire at end of intervention. Participant information will help determine if the CBT treatment is helpful for postpartum depression.