Depression is a complex mental health condition that affects millions of people across the United States. While treatments such as therapy and medication have provided relief to many, ongoing research is critical to improving outcomes and discovering new and effective solutions. Clinical trials play a pivotal role in this process, offering individuals the opportunity to participate in cutting-edge research while potentially benefiting from innovative treatments. Here’s an in-depth look at depression clinical trials in the USA, including how they work, who can participate, and what you need to know before enrolling.
What Are Depression Clinical Trials?
Clinical trials are research studies designed to evaluate new treatments, interventions, or approaches to managing a specific condition, such as depression. These trials test everything from new medications and therapies to lifestyle interventions and diagnostic tools.
In the context of depression, clinical trials aim to:
- Test the safety and efficacy of new antidepressants.
- Assess the benefits of alternative treatments, such as transcranial magnetic stimulation (TMS) or ketamine therapy.
- Develop personalized treatment plans based on genetic or biological markers.
- Study the long-term effects of existing treatments to improve their application.
These studies are conducted under strict regulations to ensure the safety of participants and the reliability of the findings.
Why Participate in a Clinical Trial?
Participating in a depression clinical trial offers several potential benefits:
- Access to Innovative Treatments: Participants may gain access to new therapies not yet available to the public.
- Personalized Care: Clinical trials often provide thorough assessments, close monitoring, and personalized treatment plans.
- Contributing to Science: By participating, individuals help advance mental health research and contribute to finding better treatments for future generations.
- Compensation: Some clinical trials offer financial compensation for time and travel expenses.
While participation has its advantages, it’s important to weigh the potential risks, including side effects from experimental treatments or the possibility of receiving a placebo.
Types of Depression Clinical Trials
There are various types of clinical trials focused on depression, each with a unique approach to research:
- Medication Trials: These studies test new antidepressants or combinations of medications to assess their effectiveness and safety.
- Therapy-Based Trials: Some trials explore the impact of cognitive behavioral therapy (CBT), dialectical behavior therapy (DBT), or other forms of psychotherapy.
- Biological and Genetic Studies: These trials investigate how genetic or biological factors influence depression and response to treatment, paving the way for personalized medicine.
- Brain Stimulation Trials: Techniques like transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), and vagus nerve stimulation (VNS) are tested for their efficacy in treating depression.
- Alternative and Lifestyle Trials: Studies may evaluate the impact of dietary changes, exercise, mindfulness, or herbal supplements on depression symptoms.
Who Can Participate in a Depression Clinical Trial?
Clinical trials have specific eligibility criteria, which vary depending on the study. Common eligibility factors include:
- Diagnosis: Participants are typically required to have a formal diagnosis of major depressive disorder (MDD), treatment-resistant depression, or another related condition.
- Age and Gender: Some trials are open to adults of all ages, while others may focus on specific demographics, such as adolescents, seniors, or women with postpartum depression.
- Previous Treatments: Certain studies target individuals who have not responded to standard treatments, while others may recruit those who are treatment-naïve.
- General Health: Participants must meet specific health requirements to ensure their safety during the trial. This may include evaluations of physical and mental health.
Before enrolling, potential participants undergo a screening process to determine their eligibility and suitability for the trial.
Here's A List Of Depression Clinical Trials In The USA
Clinical Trials.Gov allows you to search for clinical trials for Depression
App Delivered Brief Mindfulness Intervention for Surgical Patients
Study Overview
Brief SummaryThis will be a single-site, five-arm, parallel group randomized control trial involving patients undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.Official TitleApp Delivered Brief Mindfulness Intervention for Knee or Hip Replacement PatientsConditions PainAnxiety StateDepressive StateIntervention / Treatment
- Behavioral: Breath Counting
- Behavioral: Body Scan
- Behavioral: Mindful Breathing
- Behavioral: Mindfulness of Pain
- Behavioral: Mindful Savoring
Study Overview
Brief Summary
Background and Study Aims:
Secondary school students are reporting unprecedented levels of anxiety and mood difficulties. To ensure that the needs of all young people are met, there is a need to evaluate more accessible forms of support, such as psychological therapies offered in schools. The aim of this trial is to test a new form of school-based psychological therapy called Knowledge Insight Tools (KIT). KIT is based on Cognitive Behavioural Therapy, which is known to be helpful for young people experiencing difficulties with anxiety and low mood. The investigators want to see whether offering KIT to secondary school students can reduce their anxiety and/or low mood, compared to a period of time when they did not receive any support.
Who can participate?
Children and young people aged 11-18 can participate if they are attending a secondary school in England or Scotland, are experiencing problems with low mood and/or anxiety that are disrupting their everyday lives and are not mainly the result of external factors, and are actively seeking support. Children and young people cannot participate if they pose a significant risk to themselves and/or others, if their primary difficulties are not related to anxiety and/or low mood, if they have significant special educational needs or learning difficulties, and are younger than 16 years and for whom it would pose significant issues if their parents/carers were informed of their involvement with Place2Be services.
What does the study involve?
The study starts with a waiting period, where each young person will not receive any support for 3-8 weeks, except for a weekly check-in with a trained professional. This is meant to provide a stable measurement of young people's mental health before KIT is introduced. The length of the waiting period for each young person is chosen at random by a computer program. This helps mix up the influence of things other than KIT that could impact young people's mental health, such as differences in the natural (and sometimes healing) passage of time. Young people will then be offered 10 sessions of KIT, where they will learn about the ways in which unhelpful thoughts and behaviours can inadvertently make them feel low or anxious. They will also be asked to practice ways of testing their unhelpful thoughts and changing their behaviours outside of sessions, and the investigators will review how this affects their mood and well-being over the course of treatment.
What are the possible benefits and risks of participating?
The main benefit of participating is that young people will be contributing to science, which will help young people struggling with anxiety and mood problems in future be offered forms of school-based psychological therapy that have been rigorously tested. The main risk is that young people might wait longer to start KIT than had they not participated in the study. Young people will still receive KIT if they refuse to participate or withdraw their participation, which they can do at any time.
Where is the study run from?
The study is run from secondary schools in the UK and is being conducted by the Evidence-Based Practice Unit (a research group and collaboration between University College London and the Anna Freud) and researchers and school-based practitioners from Place2Be.
When is the study starting and how long is it expected to run for?
The study started on 01/08/2022 with the recruitment of the first student. The study is expected to run until September 2024. There are plans to extend the study until September 2025 if another wave of recruitment is needed.
Who is funding the study?
The study is funded by Place2Be and Anna Freud, both UK-based charities.
Who is the main contact?
The main contact and principle investigator for the trial is Professor Jessica Deighton (j.deighton@ucl.ac.uk).
Official Title
A Pragmatic Randomized Multiple Baseline Trial Evaluating Knowledge Insight Tools (KIT), a Cognitive Behavioural Therapy-informed School-based Counselling Intervention for Secondary School-aged Children and Young People With Anxiety and Mood Difficulties in the UKConditions AnxietyDepressionInternalizing ProblemsLow MoodIntervention / Treatment
- Behavioral: CBT-informed school-based counselling
Oxford Social Movement Activation Study
Study Overview
Brief Summary
For adolescents and young people particularly, there is need for better and more readily available treatments for depression and low mood. Comparatively less work has been done to characterize and treat depression specifically in young people. Previous literature indicates that often the unaddressed or under-addressed mental health difficulties in youth perseverate into adulthood and contribute to a host of individual and communal difficulties throughout the lifespan. Specifically, if depression goes unaddressed in young adulthood, the likelihood of a chronic course and multiple relapses or recurrences is much higher.
In the present research, we seek to investigate the potential efficacy of a novel intervention for young people with low mood. Depression disrupts social functioning, and social connectedness is especially important during adolescence for healthy development. Within a growing body of literature, social dance has been linked to social and mental health benefits along the dimensions of those disrupted in depression. We hypothesize that social dance might preferentially and efficiently target the goals of addressing loneliness, closeness, and enjoyment in young people compared to other approaches to the treatment of low mood and depression in a way that could lead to mood improvements.
Specifically, we are interested in the impact of a social movement-based activity, salsa dancing, on young peoples' mood and social and emotional processing. Social and emotional processing (SEP) tasks, such as emotional facial recognition and memory for emotional words, have been demonstrated to correspond with early changes that can be predictive of mood changes and treatment efficacy downstream. Including SEP tasks in this research will help to elucidate the potential mechanisms underlying mood improvements, should social dance correspond to improved mood in participants.
The present research seeks to:
- Aim 1: Investigate the effect of a social dance intervention on low mood. This will be assessed by administering psychological questionnaires to participants before, during, and after the study course of social dance sessions. In particular, we hypothesize that participants will experience reductions in low mood (assessed via the PHQ-9) following the social movement intervention as compared to a waitlist control.
- Aim 2: Characterize any early social and emotional processing changes that correspond to social dance versus a waitlist control. This will be assessed via social and emotional processing task performance before, during, and following the social movement sessions. We anticipate that improvements in social and emotional functioning as demonstrated via one or several of these tasks will assist in elucidating the possible mechanisms responsible for mood improvement from social movement.
- Aim 3: Characterize any social interaction difference from pre to post intervention that correspond to the social dance versus waitlist condition. This will be assessed via a version of the trust game before and following the social movement sessions and waitlist control. We anticipate seeing more disrupted trust behavior prior to the intervention or control conditions and less disrupted trust behavior following salsa dancing classes, but not the waitlist control.
In this randomized controlled trial, participants in the experimental group will complete six to eight sessions of social movement (salsa dance) classes within an eight-week period, and complete psychological questionnaires and tasks before, during, and after these eight weeks. Their scores will be compared with those of a control group that will participate in an active waitlist condition.
If the present study suggests that social movement benefits young people with low mood, it could form the basis for investigating a potential new cost-effective, non-invasive, accessible intervention that could be made available to young people.
What to Expect During a Clinical Trial
Participating in a clinical trial involves several steps:
- Screening: After expressing interest, you’ll undergo a screening process to ensure you meet the trial’s criteria. This may include interviews, questionnaires, and medical evaluations.
- Informed Consent: Before enrolling, you’ll receive detailed information about the trial, including its purpose, procedures, potential risks, and benefits. You’ll need to sign a consent form to participate.
- Study Phases:
- Baseline Assessments: Researchers will gather data on your current condition, including symptom severity and medical history.
- Treatment Phase: You’ll receive the assigned treatment, which could be a new drug, placebo, or therapy. Researchers will monitor your response and any side effects.
- Follow-Up: After the treatment phase, you may undergo follow-up assessments to evaluate the long-term effects of the intervention.
- Safety Monitoring: Your health and safety are closely monitored throughout the trial, with regular check-ins and support from the research team.
Success Stories: Advancements Through Clinical Trials
Depression clinical trials have already contributed to significant advancements in mental health treatment. For example:
- Ketamine Therapy: Studies on ketamine led to the approval of esketamine (Spravato), a groundbreaking treatment for treatment-resistant depression.
- Transcranial Magnetic Stimulation (TMS): Clinical trials have shown TMS to be effective for individuals who don’t respond to traditional antidepressants.
- Gene Therapy Insights: Genetic studies have identified biomarkers that predict treatment response, paving the way for personalized approaches.
These successes highlight the critical role clinical trials play in improving mental health care.
Conclusion
Depression clinical trials in the USA provide an opportunity for individuals to access innovative treatments while contributing to the advancement of mental health research. By participating in a clinical trial, you can help pave the way for new therapies that could benefit millions. Whether you’re seeking alternative treatments or looking to support the future of mental health care, clinical trials offer a valuable avenue to explore. If you’re interested, consult trusted resources, speak with your healthcare provider, and consider taking the first step toward a brighter future in depression treatment
