Mood disorders encompass a range of mental health conditions primarily affecting emotional regulation and overall mental well-being. Clinical trials in this area often explore treatment evaluations, such as medication effectiveness and psychotherapy ...
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This research aims to evaluate how a structured productivity training program affects nurses perceived job stress and their attitudes toward productivity. The study is designed as a randomized controlled experimental trial with assessments before the training, immediately after, and three months later. Researchers want to see if nurses who receive the training report lower stress and better productivity attitudes compared to those who do not. The study involves two groups an experimental group that receives a three-week productivity training totaling 20 hours, and a control group that receives no training during the same period. The training covers nursing productivity concepts, time and stress management, teamwork, leadership, digital tools, and coping with job stress. Various teaching methods like lectures, case studies, simulations, and group work are used to improve cognitive, emotional, and practical skills. Participants will complete assessments using the Nurses Attitudes Toward Productivity Scale and the Perceived Job Stress Scale at three time points before training, right after the training, and three months later. The control group also completes these assessments without receiving training during the study but will get access to the training materials afterward. The total study duration includes the training period plus follow-up assessments to monitor lasting effects.
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Young adults aged 18 to 25 who experience frequent thoughts about killing themselves are the focus of this study, which evaluates the cost-effectiveness of Attachment Based Family Therapy ABFT compared to Treatment As Usual TAU. Suicide is a leading cause of death among young adults, and current treatments have limited success. This trial aims to determine if involving family through ABFT can better reduce suicidality and improve outcomes, informing clinical guidelines and care practices in Belgium and the Netherlands. Participants are randomly assigned to one of two groups the experimental group receives ABFT as an add-on to TAU, which includes treatments like antidepressants, CBT, or DBT, with weekly ABFT sessions lasting about 16 weeks. The control group receives TAU alone, allowing up to four sessions of systemic family therapy. ABFT focuses on strengthening parent-child attachment bonds to provide a supportive base for young adults, involving parents or caregivers actively in therapy. Throughout the study, suicidality is measured at baseline, immediately after intervention, and at follow-ups 3, 6, and 12 months post-intervention using tools like the Suicidal Ideation Questionnaire Junior. Researchers also assess depressive symptoms, family functioning, attachment, quality of life, and healthcare costs. The trial includes 138 participants across multiple sites, with double-blind randomized allocation. Safety, adherence, and cost-effectiveness are closely monitored during and after the treatment period.
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Researchers are investigating the antidepressant effects of 40 Hz light stimulation in adults with Major Depressive Disorder MDD. This study builds on findings from Alzheimers disease research, where 40 Hz flickering light therapy showed promise in halting disease progression and improving cognition. The trial aims to explore whether this non-invasive neurostimulation can similarly benefit patients with depression by inducing neuroplasticity and reducing neuroinflammation. Participants will use a Neurostimulation System NSS device at home for one hour daily over six weeks. The device delivers either a 40 Hz invisible spectral flicker active setting or continuous non-flickering white light sham setting in a double-blinded, randomized placebo-controlled design. After the six-week treatment period, there is a two-week follow-up to monitor ongoing effects. During the study, participants will undergo assessments at multiple timepoints including baseline, weeks 1, 3, 6, and 8. These evaluations include depression severity rating using the Hamilton Depression Rating sub-scale HAM-D6, cognitive tests such as facial expression recognition and memory assessments, sleep quality monitoring, and quality of life questionnaires. Researchers will also analyze EEG data to explore brain activity changes related to treatment. Medication and psychotherapy regimens should remain stable throughout the study period.
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Researchers are investigating the use of 40 Hz visual stimulation as an add-on method to help improve negative symptoms, including cognitive difficulties, in people with schizophrenia or schizoaffective disorder. The study is a pilot trial comparing a group receiving visual stimulation with a group receiving their usual treatment. The goal is to assess whether this non-invasive brain stimulation method can influence brain activity patterns linked to symptoms and improve mood and cognition. Participants in the experimental group will undergo one hour of 40 Hz visual stimulation each day for five consecutive days using a customized sleep mask with red LEDs flickering at 40 Hz. They will lie down with their eyes closed and be encouraged to fall asleep during the stimulation. The control group will continue their usual treatment without additional intervention. The study includes pre- and post-assessments conducted before the first and after the last stimulation session. EEG brain activity will be recorded during the first and last stimulation sessions. Throughout the study, participants will complete mood and cognitive tests, and trained physicians will assess psychiatric symptoms. The visual stimulation sessions will be monitored for any side effects by asking participants about undesired effects after each session. EEG data will be analyzed to measure brain responses to the stimulation. The total study duration includes multiple assessment sessions before and after the stimulation week, providing detailed information on brain and symptom changes related to the intervention.
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This research aims to evaluate the effects of 5-hydroxytryptophan 5-HTP and creatine monohydrate as augmenting agents for the treatment of major depressive disorder MDD that is resistant to standard antidepressants. The study focuses on addressing the potential impact of relative hypoxia on depression through alterations in brain bioenergetics and serotonin synthesis, investigating biological markers linked to depression and antidepressant response. This phase 2 trial involves participants diagnosed with MDD who have not fully responded to selective serotonin reuptake inhibitors SSRIs or serotonin-norepinephrine reuptake inhibitors SNRIs. Participants will be randomly assigned to one of three groups for 8 weeks a low dose group receiving 5-HTP 100 mg twice daily plus creatine 5 g daily, a high dose group receiving 5-HTP 200 mg twice daily plus creatine 10 g daily, or a placebo group receiving matched placebos for both agents. The study will assess the biological and clinical effects of these treatments by measuring brain phosphorus magnetic resonance spectroscopy 31P-MRS, resting state functional connectivity imaging fcMRI, and plasma serotonin levels, aiming to replicate and extend findings from an earlier phase. During the study, participants will undergo clinical assessments including the 17-item Hamilton Depression Rating Scale to monitor changes in depression severity, as well as secondary measures like the Montgomery-Asberg Depression Rating Scale. Brain imaging and blood tests will be conducted to evaluate changes in brain energy metabolism and serotonin. Safety monitoring includes screening for medical conditions and pregnancy, with study visits scheduled over the 8-week treatment period. The total duration of participation aligns with the treatment timeline, and the study uses quadruple masking to ensure unbiased results.
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Researchers are investigating how the antidepressant citalopram affects the brains response to emotional information, focusing on the amygdala, a key brain area involved in depression. This study explores how different parts of the amygdala react to positive and negative emotional stimuli, using advanced brain scanning technology to understand the underlying brain mechanisms. Participants will receive a single oral dose of either 20 mg citalopram or a placebo in a randomized, double-blind design. After dosing, participants will undergo high-strength 7T fMRI brain scans while viewing emotional faces. This precise imaging allows researchers to observe how citalopram influences specific subfields of the amygdala during emotional processing. Participants will be screened for medical and psychiatric health before joining. During the study, brain activity and behavioral responses such as accuracy and reaction time during a gender discrimination task will be measured about three hours after dosing. The study includes safety monitoring and lasts for a few hours on the study day, focusing on neural and behavioral outcomes related to emotional processing.
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Researchers are investigating whether the enzyme phosphodiesterase 4B PDE4B is reduced in the brains of people with major depressive disorder MDD experiencing a major depressive episode MDE. This study will also explore how well a new radioactive tracer, 18FPF-06445974, can measure PDE4B in the brain, including the best scan length and reliability, as well as how PDE4B levels relate to clinical rating scales. Additionally, the study will assess if PDE4B binding can be blocked by the drug apremilast. Participants will undergo up to five clinic visits including screening, physical exams, blood tests, and heart function tests. Imaging involves MRI scans followed by PET scans where the radioactive tracer is injected intravenously through a catheter. During the PET scan, participants will be monitored closely, including blood pressure and heart rate, and blood samples will be collected via a wrist artery catheter. Some participants may have a second PET scan, a lung scan immediately after the brain scan, or receive oral apremilast to evaluate PDE4B blocking. Throughout the study, participants will complete psychiatric assessments and questionnaires about their mental state. Researchers will measure PDE4B distribution volume in the brain and examine its correlation with clinical symptoms. Safety monitoring includes vital signs before, during, and after PET scanning. The study aims to complete within several years, with the primary outcome focused on measuring PDE4B density and related scan parameters to better understand MDD.
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Researchers are evaluating a community health worker-delivered mental health counseling intervention delivered remotely via a mobile health app to reduce anxiety and depression among people living with HIV in Florida. This pilot randomized controlled trial aims to assess the preliminary effectiveness of this adapted positive affect counseling approach compared to the standard version of the app and usual mental health care. The study is sponsored by the University of Florida and focuses on improving mental health outcomes in this population. Participants will be randomly assigned to one of two groups. The intervention group will receive approximately five weekly 60-minute individual counseling sessions via secure video calls through a modified PositiveLinks app that includes enhanced mental health resources. If symptoms do not improve, participants may be referred to a licensed mental health professional. The control group will use the standard PositiveLinks app, which provides feedback on anxiety and depression symptoms and a list of local mental health resources without counseling. During the study, data will be collected from participants electronic medical records and the app for about six months after enrollment. Researchers will measure changes in anxiety and depression levels at three months as primary outcomes. Participants will provide informed consent before joining, and there is no masking or blinding in the trial. The study will monitor mental health symptoms and the use of counseling through app data and medical records to evaluate the interventions preliminary effectiveness.
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Researchers are evaluating the feasibility of a culturally adapted psychosocial intervention to support the mental well-being of Chinese immigrant pregnant women in Canada. This study focuses on women who are at least 22 weeks pregnant, over 18 years old, and speak Mandarin. The intervention is based on the Thinking Healthy Program THP, a low-intensity psychosocial therapy adapted for Chinese culture and delivered via a mobile app. Participants will use a mobile app offering three modules that cover important topics for mothers and infants during the perinatal period. Each session includes reviewing key messages, mood chart tracking, practicing healthy thinking steps, and suggested activities to complete between sessions. This intervention lasts about three weeks and is designed to be accessible on Android smartphones or emulators. During the study, participants complete questionnaires at the start, 3-4 weeks after beginning the intervention, and again 6-8 weeks after childbirth. Researchers will assess usability and acceptability of the app, recruitment and retention rates, adherence to the program, and preliminary effects on depression and related mental health measures. Some participants may also share their experiences in individual interviews. The total study participation may last around 12 months, including follow-up assessments.
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The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.
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