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Depressive Disorder, Major clinical trials

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NCT ID: NCT05516368 Completed - Clinical trials for Major Depressive Disorder

TF-CBT for Long-term PTSD, Major Depressive Disorder and Anxiety Disorders in Victims of Terrorism

Start date: March 2012
Phase: N/A
Study type: Interventional

The objective of this study is to test the efficacy of a Trauma-Focused Cognitive-Behavioural Therapy (TF-CBT) adapted for use with victims of terrorism in Spain who are diagnosed with posttraumatic stress disorder (PTSD), major depressive disorder and/or anxiety disorders subsequent to direct or indirect exposure to a series of terrorist attacks that occurred 20 years prior to treatment on average. Spanish victims who meet the criteria for long-term posttraumatic stress disorder, major depressive disorder, and/or anxiety disorders related to direct or indirect exposure to terrorist attacks that occurred 20 years ago, on average, will be randomly assigned to 16 weekly sessions of TF-CBT (experimental group) or waiting list control (control group) conditions. Between groups comparisons related to diagnostic rates and posttraumatic, depressive and anxiety symptoms will be made immediately after the intervention. Pre- follow-up comparisons related to diagnostic rates and posttraumatic, depressive, and anxiety symptoms will be carried out for the experimental group. It is hypothesised that participants receiving TF-CBT will have significantly lower diagnostic rates and mean levels of posttraumatic, depressive and anxiety symptoms than the control group immediately after the intervention, and that they will experience significant pre-treatment to 6-month follow-up decreases in diagnostic rates and in posttraumatic, depressive and anxiety symptoms.

NCT ID: NCT05431374 Completed - Clinical trials for Major Depressive Disorder

Measurement-Based Care Vs. Standard Care for Major Depressive Disorder

MBC
Start date: September 1, 2022
Phase: Phase 3
Study type: Interventional

Major depressive disorder (MDD) is one of the leading causes of disability worldwide, indicated as one of the two most disabling mental disorders by the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 (Vos et al., 2020). Despite several effective pharmacological and psychosocial interventions available globally, only about one-third of depressed patients achieve remission (Xiao et al., 2021). There is a need to establish scalable clinical management practices which utilize biopsychosocial assessments, formulate a differential diagnosis, and provide evidence-based treatments for patients with MDD (Hong et al., 2021). While significant evidence for effectiveness of Measurement Based Care (MBC) is found in clinical settings from high and middle-income countries, assessments of MBC compared with usual care for the treatment of MDD are yet to be completed in low-resource settings like LMICs. The aim of this trial is to determine the efficacy and safety of MBC in patients with MDD in comparison with standard care in Pakistan. In order to reduce the variance found in treatment-as-usual and isolate the impact of MBC, standard care for this trial will limit medication choices to either paroxetine or mirtazapine.

NCT ID: NCT05425290 Completed - Clinical trials for Cardiovascular Diseases

Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in Southern Mississippi

Start date: August 25, 2022
Phase: N/A
Study type: Interventional

The proposed study will investigate the utility of a single-session emotion regulation training to reduce CVD risk among young adults diagnosed with MDD living in Southern MS. Using an single-arm, non-randomized design, young adults aged 18-29 will undergo a single-session emotion regulation skills training. Before and immediately after the skills training session, participants will supply several biological metrics tied to CVD risk: resting HRV, inflammation (measured via c-reactive protein [CRP]), and blood pressure. Participants will provide the same biological metrics at a one-week follow-up visit to assess short-term sustained gains following the single-session intervention and complete a 7-day ecological momentary assessment (EMA) of their daily emotion regulation skills use and depressive symptoms between these two visits.

NCT ID: NCT05419869 Completed - Clinical trials for Major Depressive Disorder

Pilot Decentralized Trial

Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.

NCT ID: NCT05417087 Completed - Clinical trials for Major Depressive Disorder (MDD)

Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Start date: June 27, 2022
Phase: Phase 1
Study type: Interventional

An open label, randomized, three-period, three-treatment [Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)], six-sequence, crossover, balanced, single dose oral bioequivalence study.

NCT ID: NCT05416957 Completed - Clinical trials for Major Depressive Disorder (MDD)

Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Start date: September 18, 2022
Phase: Phase 1
Study type: Interventional

An open label, randomized, two-period, two-treatment [Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)], two-sequence, crossover, balanced, single dose oral food effect bioavailability study.

NCT ID: NCT05416762 Completed - Clinical trials for Major Depressive Disorder (MDD

Single Dose Study to Evaluate Dose-proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Start date: September 19, 2022
Phase: Phase 1
Study type: Interventional

An open label, randomized, three-period, three-treatment, six-sequence, crossover, balanced, single dose, dose proportionality study.

NCT ID: NCT05388539 Completed - Clinical trials for Major Depressive Disorder

TBS Treatment for Treatment-Resistant Depression

TTT
Start date: June 6, 2022
Phase: N/A
Study type: Interventional

Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. In this context, studies investigating the effectiveness of transcranial magnetic stimulation, including the theta burst stimulation (TBS) modality, have been increasing in number. However, there is still a lack of information seeking to explore the maximum effectiveness in the TBS modality. Therefore, the investigators developed a new stimulation protocol consisting of 3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. The protocol will be performed for 15 days, totalizing 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3) and will be performed in a Magventure MagPro R30 device. The investigators will select 100 patients with unipolar major depression, following previously established inclusion and exclusion criteria, and will apply the protocol randomly, dividing the patients into an active and placebo group. The research team hypothesized that the active group patients will have greater improvement in symptoms of depression assessed by the 17-item hamilton depression scale over patients of the placebo group. In addition, other scales will be used for secondary outcomes. The researchers also hypothesized that there will be no difference between patients placed in the active or placebo groups in terms of side effects.

NCT ID: NCT05386329 Completed - Clinical trials for Major Depressive Disorder

Therapist-Guided Smartphone-Delivered CBT for MDD

Start date: May 11, 2022
Phase: N/A
Study type: Interventional

We are testing a smartphone app that provides therapy for depression. Participants will also receive short weekly virtual appointments with a therapist. Researchers want to know if this new treatment is usable, whether participants are satisfied with it, and whether it can help lower symptoms.

NCT ID: NCT05385783 Completed - Clinical trials for Major Depressive Disorder

A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder

Start date: August 2, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The 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).