Depression

Colorado Springs, CO

78 Depression Trials near Colorado Springs, CO

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication
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SP-624 for Depression

Colorado Springs, Colorado
This trial is testing the efficacy of an investigational drug, SP-624 (study drug) to see how well it might work to treat major depressive disorder.

Trial Details

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

456 Participants Needed

NMRA-335140 for Depression

Colorado Springs, Colorado
This trial is testing a new medication called NMRA-335140 to see if it helps people with major depressive disorder. It includes participants who have no safety concerns. The medication aims to improve mood by affecting brain chemicals.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65

650 Participants Needed

Lumateperone for Pediatric Bipolar Depression

Colorado Springs, Colorado
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17

384 Participants Needed

Zelquistinel for Depression

Colorado Springs, 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

BHV-7000 for Depression

Colorado Springs, Colorado
This trial is testing a new medication called BHV-7000 to see if it is safe and well-tolerated over several months in people with Major Depressive Disorder. The goal is to help those who suffer from severe depression by potentially offering a new treatment option.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Phase 2

480 Participants Needed

Digital Therapy for Suicide Prevention

Colorado Springs, Colorado
The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions for suicidality with fidelity, this project could lead to markedly expanded access to BCBT, along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for use with patients across the full spectrum of healthcare settings, including primary care. Aviva is not an emergency alert system, rather a digital platform for delivery of the full scope of BCBT treatment components. An open-label single group Phase I clinical trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of technical features that would allow patients to revisit and/or repeat previously completed modules, along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement. These modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent with the original BCBT protocol. Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition, but also that greater app engagement will be negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e. suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will also be examined. The study will be conducted at the primary care clinics at Fort Carson, with a goal of enrolling 720 patients across a two-year timeframe. Participants will be identified using each clinic's existing suicide risk assessment methods, including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent). Participants will be randomly assigned to one of two treatment conditions, Aviva or control (i.e., development of a safety plan consistent with local procedures and policies, along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures). In an effort to address potential performance bias specific to smartphone use, participants in the control condition will download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence, identify and respond to any logistical/operational problems, and respond to any unexpected emergencies and/or participant safety concerns. Participants will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available from all participants and all time points will be included in the analyses, consistent with the intent-to-treat principle. Across our two previous clinical trials and our in-progress RCT, attrition during the first 12 months postbaseline was \<30% and we anticipate similar rates in this trial.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

400 Participants Needed

Smart Bassinet for Postpartum Depression

Colorado Springs, Colorado
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.
No Placebo Group

Trial Details

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

342 Participants Needed

Aticaprant for Depression

Colorado Springs, Colorado
This trial is testing if aticaprant can help adults with major depressive disorder who haven't responded well to current antidepressants. The medication works by targeting brain chemicals to improve mood and pleasure.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Age:18 - 64

350 Participants Needed

Treatment for Depression

Colorado Springs, Colorado
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

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

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

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

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

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

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

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.
Pivotal Trial (Near Approval)

Trial Details

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

BEET Program + CBT for Type 2 Diabetes and Eating Disorders

Aurora, 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

Power Preferred

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

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
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

140 Participants Needed

Why Other Patients Applied

"I have dealt with depression my entire adult life. I have been on multiple different meds, went through 10 weeks of TMS treatments (didn't work for me personally), done fairly extensive counseling. I’ve kind of lost hope that anything will ever help me to feel better. But I learned about new meds in clinical trials and I'm ready to try."

YP
Depression PatientAge: 60

"I have struggled with depression since I was a child. I have experienced about more than 6 major depressive episodes lasting at least 4 months since I was 7 years old. I have tried talk therapy, a plethora of medication, and nothing has worked long term. Medication and talk therapy helps me manage and reduce the length of depressive episodes but I am in search for alternative treatments. My depression has made completing a bachelors degree a major challenge."

UD
Depression PatientAge: 25

"I’m ready to move on with my life. I did a poor job bouncing back from COVID (dealing with a disability). I'd already had a PTSD diagnosis after my spouse died. These past few years have been tough and I'd like to feel like I'm alive again. I need help getting out of this phase."

FY
Depression PatientAge: 60

"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 was first diagnosed with major depressive disorder and anxiety over twenty years ago. I have tried different medications. Had to come off medications due to pregnancies, and have worked through different side effects like weight gain, nausea, sleepiness, and the more severe where i have tried to claw my way out of my skin it itched so bad. I dont want other people to have to go through this and I wish I could be off of my medication for good but it just hasnt happened. IF something is out there to improve the life of an anxious and/or depressed person I'd like to be able to say I helped find it."

HD
Depression PatientAge: 46

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

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

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

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

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

200 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

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

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

123

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