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About This Study

This trial compares two transcranial magnetic stimulation (TMS) protocols-10 Hz rTMS and intermittent theta burst stimulation (iTBS)-in adolescents with major depressive disorder. Eighty participants aged 11-19 years will be randomly assigned to receive either 10 Hz rTMS or iTBS over a two-week period. Clinical symptoms, cognitive function, brain imaging, and neurophysiological measures will be assessed at baseline, immediately post-treatment, and at a 1-month follow-up to evaluate both the immediate and sustained therapeutic effects and underlying mechanisms.

Design

Interventions / Regimen

• Device: 10 Hz Repetitive Transcranial Magnetic — Non-invasive brain stimulation using a figure-of-eight coil to deliver magnetic pulses to the left dorsolateral prefrontal cortex, with individualized neuronavigation-guided coil positioning.
• Device: Intermittent Theta Burst Stimulation — Non-invasive brain stimulation using a figure-of-eight coil to deliver magnetic pulses to the left dorsolateral prefrontal cortex, with individualized neuronavigation-guided coil positioning.

Primary Outcomes

• Change in Hamilton Depression Rating Scale-24 (HAMD-24) Total Score (Baseline, Week 2, and Week 6)

About This Study

This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours.

Design

Interventions / Regimen

• Dietary Supplement: Keto-like supplement — Participants will consume 9.25g stick packs of the keto-like supplement dissolved in water 3 times per day for 8 weeks.
• Dietary Supplement: Placebo — Participants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks.

Primary Outcomes

• BOLD response during Monetary Incentive Delay Task (week 0 pre, week 0 post, week 8)

About This Study

The goal of this clinical trial is to learn if ketamine, given during surgery, can help improve recovery for adults with serious orthopedic trauma. The study will test whether ketamine reduces pain, lowers the need for opioids, and improves mental health outcomes like depression and post-traumatic stress disorder (PTSD). The main questions it aims to answer are: Does ketamine reduce pain after surgery compared to standard anesthesia? Does ketamine reduce the amount of opioids patients need for pain control? Does ketamine improve symptoms of depression and PTSD after orthopedic trauma? Researchers will compare patients who receive ketamine during surgery with those who receive standard anesthesia without ketamine to see if ketamine helps improve both physical and psychological recovery. Participants will: Be randomly assigned to receive either a single dose of ketamine or standard anesthesia during surgery. Report their pain using a simple pain scale (Visual Analog Scale, VAS). Complete short surveys about mood and mental health (PHQ-9 for depression and PCL-5 for PTSD) at several time points after surgery. Allow the research team to review their electronic medical records to measure opioid prescriptions during recovery. Attend follow-up visits in clinic or by secure telehealth (e.g., Zoom) at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months after surgery

Design

Interventions / Regimen

• Drug: Ketamine — Participants in this group will receive a single intravenous (IV) dose of ketamine at 0.5 mg/kg, administered within 30 minutes of anesthesia induction during surgical fixation for musculoskeletal trauma. The purpose of the intervention is to evaluate ketamine's effect on postoperative pain, opioid consumption, and psychological recovery, including symptoms of depression and post-traumatic stress disorder (PTSD).
• Drug: standard general anesthesia — Participants in this group will receive standard general anesthesia during surgical fixation for musculoskeletal trauma. No ketamine will be administered. This group serves as a comparison to evaluate the effects of ketamine on pain, opioid use, and psychological recovery.

Primary Outcomes

• Pain Intensity (VAS) (1-7 days, 2-3 weeks (±1 week), 6 weeks (±2 weeks), 3 months (±3 weeks), and 6 months (±5 weeks) postoperatively.)

About This Study

This study evaluates an internet-delivered cognitive behavioural therapy for insomnia (ICBTi) intervention, known as the PSP Sleep Course, adapted for public safety personnel (PSP) experiencing sleep difficulties. The study seeks to replicate prior results from an Australian version of the Sleep Course assessing its effectiveness and acceptability when offered to Canadian PSP.

Design

Interventions / Regimen

• Behavioral: Sleep Course — The Sleep Course was previously developed and evaluated in Australia and has since been tailored to Canadian public safety personnel. The PSP Sleep Course is 7 weeks (4 lessons) and is available in self- or therapist-guided versions. Therapist-guided participants can access optional therapist support via secure online messages or phone calls (up to twice a week). Both versions are accessible for up to 6 months.

Primary Outcomes

• Insomnia (Screening, week 7 (post-treatment), and week 12 (follow-up).)

About This Study

This study is being done to learn more about the role of inflammation in depressive and cognitive symptoms in patients with depression who have played at least 11 years of organized tackle football. This will be evaluated using a medication called baricitinib, which blocks one aspect of inflammation.

Design

Interventions / Regimen

• Drug: Baricitinib — Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. Baricitinib will be dispensed every other week at the Week 2, 4, and 6 study visits. Participants who do not exhibit a clinical response (50% reduction in HAM-D scores from baseline) at Week 4 will be increased to 4 mg/day of baricitinib (2 x 2 mg tablets). A virtual follow-up visit will be conducted at Week 1 to assess safety and tolerability in all patients, and at Week 5 in patients who increase the dose.

Primary Outcomes

• Monetary Incentive Delay (MID) Task functional magnetic resonance imaging (fMRI) (Baseline and weeks 2 and 8 post-intervention)

About This Study

At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.

Design

Interventions / Regimen

• Drug: NMDAE — Use of an NMDA enhancer for the treatment of bipolar depression
• Drug: Placebo Cap — Use of placebo as a comparator.

Primary Outcomes

• Change in Visual Continuous Performance Test (week 0, 8)
• Change in Wisconsin Card Sorting Test (week 0, 8)
• Change in Logical Memory Test of the Wechsler Memory Scale (week 0, 8)
• Digit Span (week 0, 8)
• Spatial Span (week 0, 8)
• Category Fluency (week 0, 8)
• Trail Marking A (week 0, 8)
• WAIS-III Digit Symbol-Coding (week 0, 8)

About This Study

This clinical trial assesses the effect of a telecare psychosocial intervention designed for adults with spina bifida. The intervention consists of 10 weekly 1.5-hour group sessions, followed by two 3-month follow-up sessions. Each group will consist of 6 to 7 individuals. The intervention is aimed at strengthening aspects of self-concept, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.

Design

Interventions / Regimen

• Behavioral: Psychosocial teleassistance intervention — The teleassistance psychosocial intervention involves 10 weekly 90-minute group sessions, with each group comprising 6 to 7 participants. These sessions are designed to enhance self-concept, self-esteem and social skills, reduce symptoms, and improve overall psychological well-being. Two follow-up sessions will be provided three months after the main program concludes.

Primary Outcomes

• Quality of life - The World Health Organization WHOQOL-BREF Quality of Life Assessment (3 months after the intervention)
• Anxiety and depression - The Hospital Anxiety and Depression Scale (3 months after the intervention)
• Depression - The Patient Health Questionnaire (3 months after the intervention)
• Self-esteem - The Rosenberg Self-Esteem Scale (3 months after the intervention)
• Self-Concept - Self-Concept Questionnaire Form-5 (3 months after the intervention)

About This Study

The purpose of this study is to assess the effects of polyphenols from natural aronia juice on the immune system. Therefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as polyphenols and carotenoids in healthy and depressive subjects in order to use the known positive effects of these food sources in the therapeutic setting. The consumption of natural fruit juices that are rich in polyphenols and carotenoids mirror a model of vegetarian diet due to the increased micronutrient density derived from plant food. Results obtained here can be seen as preliminary explanation models for the beneficial effects of vegetarian diet. It is hypothesized, that the consumption of naturally polyphenol rich aronia juice changes the expression of regulatory T cells, specific cells of the immune system that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, the metabolome and the nutritional status are expected in the studied groups. The study was registered retrospectively (after start of recruitment) on Clinicaltrials.gov.

Design

Interventions / Regimen

• Other: Aronia Juice — The intervention is based an the additional consumption of 200 ml natural juice a day for a period of six weeks. The participants are asked to drink the natural and commercially available juice in addition to their regular diet. Further, they are asked not to change their diets and lifestyle behaviour during the intervention.
• Other: Placebo — A beverage is prepared according to a known recipe. It contains macro- and micronutrients in comparable amounts like the aronia juice. It is completely polyphenol free.

Primary Outcomes

• Change of baseline regulatory T cells (Tregs) at 6 weeks (after the intervention) (Determination at baseline (day 0) and after 6 weeks (after the intervention))
• Change of baseline regulatory T cells (Tregs) at 12 weeks (after the intervention and another 6 weeks of wash out) (Determination at baseline and after 12 weeks (after the 6-weeks intervention and another 6 weeks of wash out))

About This Study

The goal of this clinical trial is to evaluate the effectiveness of an 8-week mindfulness lifestyle social prescribing program in community-dwelling older adults aged 55 and older. The main questions it aims to answer are: To establish a mindfulness lifestyle social prescribing model applied to the psychological and social health promotion of middle-aged and older populations. To evaluate the effectiveness of the intervention on improving depressive symptoms, loneliness, and quality of life in this population. Participants will receive an 8-week group intervention program, with each weekly session lasting approximately 3 hours. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). Researchers will collect and evaluate data from pre- and post-intervention assessments to measure changes in depressive symptoms, loneliness risk, and overall quality of life.

Design

Interventions / Regimen

• Behavioral: Mindfulness Lifestyle Social Prescribing Program — An 8-week, once-weekly, 3-hour group program designed for middle-aged and older adults. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). It is delivered by a multidisciplinary team including geriatricians, case managers, dietitians, exercise instructors, and volunteers.

Primary Outcomes

• Changes in Geriatric Depression Scale (GDS-15) score (Baseline and Week 8)
• Changes in UCLA Loneliness Scale score (Baseline and Week 8)
• Changes in WHOQOL-BREF questionnaire score (Baseline and Week 8)

About This Study

The goal of this open clinical trial is to try out and evaluate a group metacognitive treatment protocol, for adolescents aged 15-18 years of age with anxiety and/or depression and an autism diagnosis. The main questions it aims to answer are: 1. How does the recruitment to the study work and what is the retention rate? 2. What is the level of participant compliance? 3. Is the treatment adherence satisfactory, are there any practical problems with treatment delivery? 4. Are the outcome measures and assessment procedures feasible? 5. Do the participants accept the treatment, are there any reports of adverse effects? 6. What are the preliminary effects of the treatment regarding 1. Symptoms of anxiety and/or depression 2. Quality of life 3. Functional impairment 4. Subjective level of stress 5. Central metacognitive processes 7. Are changes in metacognitive processes related to changes in anxiety and depression? The participants will partake in metacognitive group treatment of 10 sessions following an initial screening.

Design

Interventions / Regimen

• Behavioral: A metacognitive group therapy of depression and anxiety in youth with autism — The treatment model is based on Adrian Wells' transdiagnostic A-M-C model and treatment structure described in Wells (2009) "Metacognitive therapy for anxiety and depression". The group treatment is delivered in 10 weekly sessions.

Primary Outcomes

• Revised Children's Anxiety and Depression Scale (RCADS) (Change from pre intervention to treatment completion at 10 weeks and at a 6 month follow-up)

About This Study

The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in improving social and role functioning in Veterans recently discharged from Cardiovascular disease (CVD-related) inpatient care. Eligible participants will receive either (1) twelve sessions of BA-HT or (2) standard best practices post CVD hospitalization care. Study participants will be 132 Veterans discharged from the Ralph H. Johnson VA Medical Center inpatient care facilities with CVD diagnoses corresponding to ICD 10 codes I20-I25 (120 unstable angina, stable angina; 121 Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), ST-elevation myocardial infarction (STEMI), initial encounter; 122 NSTEMI, STEMI, subsequent encounter; 124 acute coronary syndrome; 125 coronary arteriosclerosis with angina). They will be male or female, age 21 and above, and with approximately 40-50% minority representation. There will be assessment at baseline, 1 week post treatment, as well as 3 and 9-months post treatment. The investigators predict that BA-HT will more effectively increase social role and activity functioning, activity, mood and reduce 9-month re-hospitalization compared to current best-practices post-discharge care among patients scoring at least moderately depressed on the PROMIS Depression scale one week following hospital discharge for a CVD event.

Design

Interventions / Regimen

• Behavioral: BA-HT — Behavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software.
• Other: Standard Care — Best practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery.

Primary Outcomes

• PROMIS Ability to Participate in Social Roles and Activities (13 weeks)
• PROMIS Satisfaction with Participation in Social Roles (13 weeks)
• PROMIS Physical Function with Mobility Aid (13 weeks)

About This Study

A prospective longitudinal cohort study that will assess the effect of a Personalized Medicine (PM) clinic recommendations on pharmacogenetic variation and/or interacting drugs on plasma drug exposure, effectiveness or toxicity of commonly used antidepressant, pain, and antiemetic medications in cancer patients. Such recommendations will entail genotype-guided treatment suggestions while also considering potential DDI, and will be provided to patients during their clinic visit, and referring physicians thereafter. Drug concentration and therapeutic effectiveness will be assessed before (baseline) and 6 months after recommendations have been provided. To assess effectiveness, patient-reported outcomes will be evaluated using validated scales for symptoms of depression, pain and chemotherapy-induced nausea/ vomiting The investigators hypothesize that the pharmacogenetic variation and DDI, if applicable, determine steady state drug concentration and therapeutic response or toxicity of the investigated antidepressant, pain or antiemetic treatments at baseline, while there is a clinically significant reduction or absence of the effect 6 months after the PM clinic recommendations to referring physicians and patients.

Design

Interventions / Regimen

• Genetic: Pharmacogenetic testing — Genotyping for CYP2D6 and CYP2C19
• Other: Drug-Drug interaction analysis — Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.

Primary Outcomes

• Drug level measurements (Baseline visit to 6 months)