An Intervention Study to Evaluate a Medication (MIJ821) Used to Treat Major Depressive Disorder

Official Title
Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
Purpose

The purpose of the study is to determine if the investigational study drug will rapidly reduce depression associated with thoughts of harming oneself when given in addition to standard antidepressant medication.

Your participation in this study will last for a minimum of 14 weeks and maximum of 58 weeks.

Could this study be right for you?

• Aged 18-65 years old
• Diagnosed with major depressive disorder (MDD) with a current major depressive episode
• Having current suicidal ideation with intent
• Already in the hospital or agree to be hospitalized voluntarily for the required period of time

Age Range
18 and up

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

Official Title
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Purpose

This study is being done to see if the study drug, called BI 1358894, compared to a drug called quetiapine, may help people with Major Depressive Disorder (MDD) who do not progress when taking an antidepressant medication alone. This study will help to gain information for providing better or new possible treatments for people in the future.

This study will take place over a period of 13 weeks and have about 8 visits to the study center and 2 that will be done by phone.

Could this study be right for you?

• Aged 18-65 years old
• Diagnosed with Major Depressive Disorder (MDD)
• Currently depressed
• Taking an antidepressant

Age Range
18 and up

A Study to Evaluate the Safety of REL-1017, A Study Drug Used to Treat Major Depressive Disorder (MDD)

Official Title
Safety of REL-1017 for Major Depressive Disorder (RELIANCE-OLS)
Purpose

This is a 1-year open-label study to access the safety of REL-1017, a study medication, once daily as a workable treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.

This study will last 13 months and you will come to the study site at least 15 times over this period. This will include 1 final visit about 1 month after you stop taking the study drug.

Could this study be right for you?

• Aged 18-65 years old
• Diagnosed with Major Depressive Disorder (MDD)
• Currently depressed
• Taking or having taken between 1 and 3 antidepressants for the current episode of depression

Age Range
18 and up

Study to Assess the Efficacy and Safety of Adjunctive NBI-1065845 in Adults with Major Depressive Disorder (MDD) (SAVITRI)

Official Title
Study to Assess the Efficacy and Safety of Adjunctive NBI-1065845 in Adults with Major Depressive Disorder (MDD) (SAVITRI)
Purpose

The purpose of this study is to evaluate the effectiveness and safety of NBI-1065845 compared with placebo. In addition to the study drug, participants will continue their normal antidepressant medications. The main goal of this study is to examine the improving symptoms of depression.

The duration of the study will last 14 weeks, including up to 4 weeks of screening, 8 weeks of study drug dosing, and a follow-up period of 2 weeks.

Could this study be right for you?

• Aged 18-65 years old
• Have a diagnosis of Major Depressive Disorder (MDD)
• Currently depressed
• Poor response to antidepressant treatment

Age Range
18 and up

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

Official Title
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)
Purpose

The purpose of this study is to examine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

The duration of the study will consist over a 5 year period. You will visit the study site approximately 23 times after your implant surgery.

Could this study be right for you?

• Aged 18 years or older
• Must be in a major depressive episode (MDD or bipolar disorder) for ≥ two years or have at least had four episodes of depression including the current episode
• Patients depressive illness meets a minimum criteria of four prior failed treatments of adequate dose and duration

Age Range
18 and up

A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants with Treatment-resistant Depression

Official Title
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants with Treatment-resistant Depression
Purpose

The purpose of this study is to see if esketamine nasal spray alone is effective as a medication to improve depressive symptoms in adults with treatment-resistant depression when compared with placebo nasal spray.

The duration of the study consists up to a maximum of 24 weeks.

Could this study be right for you?

• Aged 18 years or older
• Must have had no response (less than 25% improvement) to at least 2 oral antidepressant treatments in the current episode of depression

Age Range
18 and up

A Study About Brain Activity and Suicide Prevention Strategies

Official Title
Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy
Purpose

This research study will look at how patterns of brain activity influence thoughts and behaviors. This research is being done to better explain why people have thoughts about suicide and how different suicide prevention strategies impact brain responses to emotional information.

Could this study be right for you?

Eligibility Criteria includes:
- 18-65 years old
- generally medically and physically healthy
- current suicidal ideation and intent OR no lifetime history of DSM-5 disorder, no lifetime suicidal intent or lifetime suicide attempts
(partial list of inclusion criteria)

Exclusion Criteria:
- Diagnosis of bipolar disorder, schizophrenia, mania, or psychosis
- Currently pregnant (positive pregnancy test), or trying to become pregnant (female)
- Presence of ferrous-containing metal in the body
- Inability to tolerate enclosed spaces
(partial list of exclusion criteria)

Age Range
18 and up

Mapping Individual Differences in Mood and Personality - The MindMap Study

Official Title
Mechanisms of Negative Affectivity
Purpose

Symptoms related to depression and anxiety can affect a person’s daily life and relationships. Some research suggests that people with mood and anxiety disorders process information differently than people without these types of disorders.

The purpose of this study is to better understand the way the brain works in people who have depression and anxiety. Researchers hope their findings will lead to better ways to diagnose and treat mood and anxiety disorders in the future.

Participation involves an initial phone call and a 3 to 5 hour visit to find out if you are eligible. This visit will include completing questionnaires and interviews. If eligible, participants will have a second 3-5 hour visit for an MRI scan.

The 3rd and 4th visits (at 6 and 12 months) will include 1.5 to 3 hours of questionnaires and interviews each.

Following the scan, the 6-month follow-up, and the 12-month follow-up, participants will also complete daily online questionnaires for 7 days.

Could this study be right for you?

You may be eligible for this study if you are:
• 18-25 years of age
• Right-handed
• Currently experiencing symptoms of depression or anxiety (feeling down or depressed, anxious, nervous, or tense, having no interest in things you used to enjoy, or feeling hopeless)
• Not currently receiving treatment (psychiatric medications or therapy)
• No major medical problems (e.g., stroke, heart disease, high blood pressure, endocrine disorders, etc.)
• No history of neurological disorders (e.g., seizures, head injury, etc.)
• Normal vision, vision that is corrected to normal with glasses or contacts
• Willing and able to undergo fMRI scanning (not claustrophobic, no non-removable metal in your body)
• Not pregnant

Participation involves an initial phone call and a 3 to 5 hour visit to find out if you are eligible. This visit will include completing questionnaires and interviews. If eligible, participants will have a second 3-5 hour visit for an MRI scan.

The 3rd and 4th visits (at 6 and 12 months) will include 1.5 to 3 hours of questionnaires and interviews each.

Following the scan, the 6-month follow-up, and the 12-month follow-up, participants will also complete daily online questionnaires for 7 days.

Age Range
18 and up

Evaluating the Effectiveness of a Study Drug and Quetiapine in People with Depression

Official Title
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in people with Depression
Purpose

The purpose of this study is to see if a new drug (BI 1358894), taken in addition to a current antidepressant, is useful and safe for treating patients with Major Depressive Disorder.

You will be in this study approximately 13 weeks and have about 8 visits to the study center. You will also have about 2 visits that will be done by phone.

Could this study be right for you?

Inclusion criteria:
- Between the ages of 18 and 65
- Currently taking an antidepressant
- Currently experiencing symptoms of depression

Age Range
18 and up

The Family Risk Study

Official Title
Parental History of Suicidal Behavior and Early Markers of Risk in Pre-pubescent Youth
Purpose

The purpose of this study is to learn what factors may be related to suicide attempt(s) in children (ages 6 - 9) that have a parental history of suicidal behavior in hopes that this information will help prevent and treat self-harm behavior in youth at high risk.

Both parents and children will complete questionnaires, interview questions, and a family discussion in addition to problem solving tasks and computer games.

There are multiple study visits. The first will last about 2.5 to 3 hours and all other appointments will occur annually from your first appointment. Due to COVID-19, families will have the option to conduct annual follow-up appointments via telephone. These annual telephone visits will last approximately 30-45 minutes. If the annual visit is conducted in-person, it will last 1.5 to 2.5 hours.

Could this study be right for you?

- Parents and children must be able to read and understand English fluently
- Child is 6 to 9 years of age
- Meet other criteria (e.g., no traumatic brain injury) for the study

Age Range
6 and up