Depression

Denver, CO

32 Depression Trials near Denver, CO

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication
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MM120 for Depression

Denver, Colorado
A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Major Depressive Disorder - Emerge
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

140 Participants Needed

Active on Power

Psychedelic-Assisted Therapy for Treatment Resistant Depression

Denver, Colorado
This study is testing VLS-01, a treatment containing DMT that is placed in the mouth and dissolved, to see if it can quickly help people with depression who haven’t improved with other treatments. Participants will receive either 1 or 3 doses of VLS-01, with support throughout the study, to evaluate its safety and effectiveness.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65

142 Participants Needed

Psilocybin Analog for Depression

Denver, Colorado
The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
Stay on current meds
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

220 Participants Needed

Zelquistinel for Depression

Denver, Colorado
The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults. It will also learn about the safety of GATE-251. The main questions it aims to answer are: Does GATE-251 reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no GATE-251)? What medical problems are observed in participants who take GATE-251? Participants will take one tablet of GATE-251 or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 64

164 Participants Needed

Psilocybin for Depression

Denver, Colorado
This trial is testing psilocybin, a substance from mushrooms, to see if it can help adults with depression who may not respond well to current treatments. Psilocybin works by affecting brain chemicals related to mood. Psilocybin has shown promise as a treatment for major depressive disorder and was designated as a breakthrough therapy by the FDA in 2019.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Male

240 Participants Needed

RE104 for Postpartum Depression

Denver, Colorado
This trial is testing whether a single injection of RE104 can help reduce depression in women who have moderate-to-severe postpartum depression. The goal is to see if this treatment works effectively. The exact way RE104 works isn't detailed, but it likely helps by affecting brain chemicals related to mood.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 45
Sex:Female

72 Participants Needed

Parenting Skills Group for Postpartum Depression

Denver, Colorado
The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: * Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? * Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? * Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will * Participate in an 8-week COSP program delivered remotely via Zoom. * Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. * Complete a series of assessment questionnaires delivered remotely. * Videotape a play-based assessment in their home. * Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female

750 Participants Needed

In-Person vs. Virtual Therapy for Postpartum Depression

Denver, Colorado
The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

900 Participants Needed

Seltorexant for Depression

Denver, Colorado
This trial is testing seltorexant to see if it can help people with depression and insomnia who haven't improved with their current antidepressants. Seltorexant aims to improve mood and sleep by acting on certain brain receptors.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting

752 Participants Needed

Health Screening and Referral for Premature Birth

Denver, Colorado
Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH). Preterm infants are especially vulnerable to the social conditions they grow up in, with sustained impacts on function across multiple organ systems. The goal of this study is to translate an established model of SDOH screening and referral from the outpatient setting to the NICU, thereby maximizing the potential to offset the effects of adverse SDOH on vulnerable mother-preterm infant dyads.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Sex:Female

882 Participants Needed

BEET Program + CBT for Type 2 Diabetes and Eating Disorders

Denver, Colorado
Disordered eating behaviors (DEBs, e.g., binge eating or restrictive eating) can significantly impact type 2 diabetes (T2D) self-management and engagement in treatment for diabetes. Managing DEBs is a treatment component in diabetes self-management; however, it is not often the primary focus, and trained behavioral health providers are inconsistently involved in comprehensive diabetes management. This study plans to pilot two behavior change programs for disordered eating in T2D and gather information on factors that predict successful adoption and implementation in real-world clinical settings.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 65

80 Participants Needed

Cognitive Behavioral Therapy for Depression and Suicide Prevention

Aurora, Colorado
This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65

472 Participants Needed

Cannabis for Palliative Care in Cancer

Aurora, Colorado
Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:25+

185 Participants Needed

Psilocybin for Depression

Aurora, Colorado
The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:21 - 75

40 Participants Needed

Hormonal Contraceptives for Depression

Aurora, Colorado
Purpose of this study: The purpose of this study is to learn more about how hormonal oral contraceptives affect brain processes and emotional wellbeing. Procedures: If participants agree to participate, the following will happen: 1. Eligibility visit (remote screening session) 2. If participants are eligible to participate in the study, they will be placed in one of two groups. If they are in the first group, they will be asked to take an oral contraception pill ("study drug") every day for 21 days. If they are in the second, they will take a placebo every day for 21 days. A placebo is a pill that looks like medicine but is not real and will have no medical effect on participants. Participants will not get to choose which group they are in, nor will they be told which group they are in. 3. During the three-week period in which participants will take either the study drug or placebo, they will be asked to complete daily check-in surveys on their computer or mobile device. 4. Participants will be asked to attend two additional visits over the course of about three weeks. At these visits, participants will be asked to undergo a urine drug screen, a blood draw, and a magnetic resonance imaging (MRI). They will also be asked to complete behavioral questionnaires.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 45
Sex:Female

144 Participants Needed

Pramipexole vs Escitalopram for Depression in HIV

Aurora, Colorado
A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 2

186 Participants Needed

Cognitive Behavioral Therapy for Depression and Insulin Sensitivity in Adolescents

Aurora, Colorado
There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies, the investigators found that a brief cognitive-behavioral therapy group decreased depressive symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a cognitive-behavioral therapy depression group vs. a health education control group for improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up; 2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test changes in cortisol factors as explanatory.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 17
Sex:Female

147 Participants Needed

Mindfulness-Based Therapy for Depression

Aurora, Colorado
Rates of type 2 diabetes (T2D) in adolescents have escalated. Adolescent-onset is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, a physiological precursor to T2D. T2D prevention standard-of-care is lifestyle intervention to decrease insulin resistance through weight loss; yet, this approach is insufficiently effective in adolescents. Adolescents at risk for T2D frequently experience depression, which predicts worsening insulin resistance and T2D onset, even after accounting for obesity. Mindfulness-based intervention (MBI) may offer a targeted, integrative health approach to decrease depression, and thereby, ameliorate insulin resistance in adolescents at risk for T2D. In a single-site, pilot randomized controlled trial (RCT), we established initial feasibility/acceptability of a 6-week group MBI program, Learning to BREATHE, in adolescents at risk for T2D. We demonstrated feasible single-site recruitment, randomization, retention, protocol adherence, and MBI acceptability/credibility in the target population. Our preliminary data also suggest MBI may lead to greater reductions in stress-related behavior, vs. CBT and a didactic/health education (HealthEd) control group. The current study is multisite, pilot RCT to test multisite fidelity, feasibility, and acceptability in preparation for a future multisite efficacy trial that will have strong external validity, timely recruitment, and long-term follow-up. Adolescents (N=120) at risk for T2D will be randomized to MBI vs. CBT vs. HealthEd and followed for 1-year. Specific aims are to: (1) test multisite fidelity of training and implementation of 6-week group MBI, CBT, and HealthEd, to teens at risk for T2D; (2) evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for an RCT of 6-week group MBI, CBT, HealthEd with 6-week and 1-year follow-up; and (3) modify intervention training/implementation and protocol procedures in preparation for a future, fully-powered multisite efficacy RCT.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:12 - 17

120 Participants Needed

Group Therapy for Depression in Teens with Type 2 Diabetes

Aurora, Colorado
The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:12 - 17

50 Participants Needed

CBT + Exercise for Diabetes Prevention in Adolescents

Aurora, Colorado
The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 17
Sex:Female

300 Participants Needed

Why Other Patients Applied

"I've used SSRIs (Lexapro, Celexa) and they helped a bit but also, truthfully, they've had pretty serious sexual side effects. Depression was already hurting my marriage, and now these drugs continue to paralyze my it. I've heard that psilocybin-based treatments typically have no sexual side effects... I think a clinical trial will let me try safely."

LN
Depression PatientAge: 44

"I'm taking a medication for anxiety and it's not helping/working. I want to try and find something that would help with my anxiety. My research brought me to clinical trials."

ZD
Social Anxiety PatientAge: 36

"Dealt with treatment-resistant depression for pretty much my entire life. I would be eternally grateful for something that actually worked for once. I'd just like to feel normal. "

CM
Depression PatientAge: 55

"Tried Lexapro, Wellbutrin and another (forget which). Surgical accident destroyed my mental nerve and left me in chronic pain, depression, and anxiety. That was 15 years ago. Disabled and retired. I'm tired of this."

IH
Depression PatientAge: 73

"I have struggled my entire life with depression. I feel like it took away half my life because I've been unable to truly feel the good times and people around me, like I'm numb. I would like to take part to see if it might help me, but I would also like to help others by doing this trial if I am accepted. I would love to enjoy life and truly feel the happy experiences that might come my way rather than observe them without feeling."

EW
Depression PatientAge: 45

Whole Health Intervention for PTSD

Aurora, Colorado
This trial tests Omnis Salutis, a program for recent veterans of the Afghanistan and Iraq conflicts. The program helps veterans set and share their health goals with doctors and support systems to improve their well-being.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65

238 Participants Needed

High-Dose Exercise for Concussion Recovery

Aurora, Colorado
Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:13 - 18

216 Participants Needed

Guided Imagery for Head and Neck Cancer

Aurora, Colorado
The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers relative to treatment as usual.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting

57 Participants Needed

PATH Program for NICU Parent Mental Health

Aurora, Colorado
The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

72 Participants Needed

Mindfulness-Based Intervention for Type 1 Diabetes

Aurora, Colorado
Type 1 diabetes (T1D) is a common chronic illness among children requiring a high degree of self-management for good glycemic control. Adolescents are at risk for poor disease management and health outcomes due to a number of factors, including high rates of depression, anxiety, and stress. Accessing support for these challenges can be a barrier to care, so the current study, BRinging Empowerment and Attention to Teen HEalth-T1D, evaluates the efficacy of a virtual, group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety, and diabetes self management in teens with T1D. The study also aims to study how these interventions might be implemented in diabetes clinic settings.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 17

200 Participants Needed

Virtual Stress Management for Caregiver Stress

Denver, Colorado
This randomized control trial will investigate the ability of an effective stress management psychoeducation program for employed caregivers to mitigate psychological distress and pathophysiology in spousal or partnered caregivers of patients' diagnosis with a solid tumor cancer of any stage. It is expected that improving caregiver status will have reduced depressive symptoms.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 64

510 Participants Needed

Palliative Care Intervention for Advanced Cancer

Boulder, Colorado
Adults diagnosed with metastatic cancer commonly experience depression and anxiety symptoms, which can interfere with advance care planning. This randomized clinical trial evaluates a novel, piloted, primary palliative care intervention that addresses advance care planning and psychosocial needs of patients with metastatic cancer. The intervention focuses on patients with elevated anxiety and depression (anx/dep) symptoms-those with highest psychosocial needs who may be at greatest risk for advance care planning non-completion. The intervention is founded on an evidence-based intervention approach known as Acceptance and Commitment Therapy (ACT) that reduces distress and promotes behavior change through theory-driven mechanisms. In the proposed randomized trial, M-ACT will be compared to a usual care control condition. The study will also assess the association between advance care planning and anx/dep symptoms, thereby informing the critical practice question of whether anx/dep symptoms should be addressed concurrently with advance care planning. The study will enroll patients with Stage IV solid tumor cancer (N=240) within Rocky Mountain Cancer Centers, randomized 1:1 to M-ACT or usual care. The study aims to: 1) Evaluate the hypothesis that M-ACT will increase advance care planning completion (primary outcome) and sense of life meaning, and reduce anx/dep symptoms and fear of dying relative to usual care control. 2) Assess the association between anx/dep symptoms and advance care planning at baseline and over time, testing the hypothesis that decreases in anx/dep symptoms at post- intervention will be associated with increases in advance care planning at follow-up. 3) Assess M-ACT's hypothesized mechanisms to specify how the intervention works (exploratory aim). Given their advance care planning and psychosocial needs, and poor access to palliative care, rigorously investigating M-ACT has the potential to benefit community patients with metastatic cancer and to advance palliative care science by addressing gaps in novel approaches, foundational knowledge, and the scalable delivery of palliative care. Note: Due to the coronavirus pandemic, the in-person group component of M-ACT has currently been shifted to an online group format.
No Placebo Group

Trial Details

Trial Status:Recruiting

240 Participants Needed

Cannabidiol for Older Adult Cannabis Users

Boulder, Colorado
Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:60+

385 Participants Needed

BT5528 for Solid Cancers

Denver, Colorado
This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: * Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab * Learn more about the side effects of BT5528 * Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. * Learn more about BT5528 therapy alone and in combination with nivolumab.
No Placebo Group
Prior Safety Data

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1, 2

288 Participants Needed

Venetoclax + Chemotherapy for B-Cell Lymphoma

Denver, Colorado
This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3

363 Participants Needed

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