Prozac

Premature Ejaculation, Cataplexy, Bulimia Nervosa + 11 more

Treatment

6 FDA approvals

20 Active Studies for Prozac

What is Prozac

Fluoxetine

The Generic name of this drug

Treatment Summary

Fluoxetine is an antidepressant medication that was approved by the FDA in 1987. It belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs) and is used to treat depression. It has since been used to treat other mental health conditions as well.

Prozac

is the brand name

image of different drug pills on a surface

Prozac Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Prozac

Fluoxetine

1987

490

Approved as Treatment by the FDA

Fluoxetine, also known as Prozac, is approved by the FDA for 6 uses such as Premenstrual Dysphoric Disorder (PMDD) and Bipolar 1 Disorder .

Premenstrual Dysphoric Disorder (PMDD)

Bipolar 1 Disorder

Used to treat Bipolar 1 Disorder in combination with Olanzapine

Major depressive disorder, recurrent episode

Used to treat Major depressive disorder, recurrent episode in combination with Olanzapine

Bipolar Disorder

Used to treat Bipolar 1 Disorder in combination with Olanzapine

Depression

Used to treat Depression in combination with Olanzapine

Unipolar Depression

Used to treat Major depressive disorder, recurrent episode in combination with Olanzapine

Effectiveness

How Prozac Affects Patients

Fluoxetine works by keeping serotonin levels high in certain parts of the brain. It has a milder effect on other receptors like dopamine, adrenaline, and histamine compared to other types of antidepressants, which makes it have fewer side effects.

How Prozac works in the body

The monoaminergic hypothesis of depression suggests that low levels of serotonin are linked to depression. Fluoxetine is a drug designed to help treat this type of depression. It works by increasing the amount of serotonin available in the brain. It does this by blocking the reuptake of serotonin, which essentially traps it in the brain. Fluoxetine has a strong affinity for serotonin, but only a weak affinity for noradrenaline and no affinity for dopamine. Additionally, it interacts with the 5-HT2C receptor, which increases noradrenaline and dopamine levels in the prefrontal cortex.

When to interrupt dosage

The recommended dosage of Prozac is contingent upon the diagnosed condition, such as Myoclonus, Bipolar Disorder and Unipolar Depression. The dosage amount is dependent upon the administration technique (e.g. Tablet, coated or Oral) detailed in the table below.

Condition

Dosage

Administration

Premature Ejaculation

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Cataplexy

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Bulimia Nervosa

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Anorexia Nervosa

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Panic Disorder

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Alcoholism

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Unipolar Depression

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

moderate to severe symptoms

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Depression

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Myoclonus

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Bipolar Disorder

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

maintenance therapy

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Obsessive-Compulsive Disorder

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Depression

, 90.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 25.0 mg, 50.0 mg, 60.0 mg, 20.0 mg/mL, 15.0 mg

Oral, Capsule, delayed release - Oral, , Capsule, delayed release, Capsule, Capsule - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, delayed release pellets, Capsule, delayed release pellets - Oral, Kit, Solution, Solution - Oral, Liquid, Liquid - Oral, Tablet, coated, Tablet, coated - Oral

Warnings

Prozac Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Prozac.

Common Prozac Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be decreased when combined with Fluoxetine.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be decreased when combined with Fluoxetine.

Alectinib

Major

The metabolism of Alectinib can be decreased when combined with Fluoxetine.

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Fluoxetine.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Fluoxetine.

Prozac Toxicity & Overdose Risk

Most cases of fluoxetine overdose have mild, short-term side effects such as sleepiness, trembling, fast heart rate, nausea, and vomiting. However, in rare cases, serious symptoms may occur. For example, one patient took 1400mg of fluoxetine in a suicide attempt and had a seizure 3 hours later. Another patient took 1.2g of fluoxetine and experienced seizures, symptoms related to serotonin syndrome, and muscle breakdown.

image of a doctor in a lab doing drug, clinical research

Prozac Novel Uses: Which Conditions Have a Clinical Trial Featuring Prozac?

881 active clinical trials are being conducted to evaluate the efficacy of Prozac in treating Disease, Anorexia Nervosa and as a maintenance therapy.

Condition

Clinical Trials

Trial Phases

Depression

213 Actively Recruiting

Phase 3, Phase 2, Not Applicable, Phase 4, Phase 1, Early Phase 1

Bipolar Disorder

0 Actively Recruiting

Unipolar Depression

48 Actively Recruiting

Not Applicable, Phase 4, Early Phase 1, Phase 3, Phase 2, Phase 1

Bulimia Nervosa

0 Actively Recruiting

Alcoholism

7 Actively Recruiting

Not Applicable, Phase 2, Phase 3

Anorexia Nervosa

0 Actively Recruiting

moderate to severe symptoms

0 Actively Recruiting

Depression

305 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Early Phase 1, Phase 4, Phase 3

Panic Disorder

0 Actively Recruiting

Obsessive-Compulsive Disorder

66 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 1, Early Phase 1

maintenance therapy

0 Actively Recruiting

Myoclonus

1 Actively Recruiting

Not Applicable

Cataplexy

0 Actively Recruiting

Premature Ejaculation

0 Actively Recruiting

Prozac Reviews: What are patients saying about Prozac?

5

Patient Review

6/7/2022

Prozac for Depression

Prozac was very effective at treating my symptoms, but I experienced some significant weight gain as a result. L-Tryptophan was much more holistic in its approach and helped me feel better overall.

5

Patient Review

8/30/2022

Prozac for Repeated Episodes of Anxiety

This medication has only been a part of my life for a short time, but it's already made such a big difference. I can think more clearly, sleep through the night, and feel more in control of my body and mind. The best part is that other people are noticing the changes too. My husband told me the other day that he hasn't seen me smile in years and this medicine helped him get his wife back. I'm so grateful for this treatment; it feels like I've gotten my life back.

4.7

Patient Review

2/9/2022

Prozac for Major Depressive Disorder

Being on Prozac has definitely helped me get back to functioning like a normal person again. I'm so grateful for this medication!

4.7

Patient Review

4/20/2022

Prozac for Depression

I was pretty dubious about this treatment at first, especially because it took a few weeks to see any effects. But I'm so glad I stuck with it! After increasing my dosage to 20mg, I've seen significant changes for the better in my mood and overall outlook on life.

4.3

Patient Review

11/7/2022

Prozac for Premenstrual Disorder with a State of Unhappiness

I've tried a lot of different medications for my PMDD, and this is the only one that's really given me any relief. And it comes with very few side effects, if any.

4

Patient Review

5/6/2022

Prozac for Bipolar Depression

Prozac has been a great addition to my bipolar depression medication. I've been on a low dose because Prozac can possibly trigger mania, but it really helps with my winter depression. As long as I monitor my moods, I haven't had any issues.

3.3

Patient Review

5/18/2022

Prozac for Depression

I first tried prozac when I was 22. It worked well for a while, but then I stopped taking it. I went back on it when I was 40 and experienced more than 10 panic attacks per day. I thought it was the hospital environment that was causing the panic attacks, but after being discharged, the panic attacks continued. So, I got a new doctor who took me off the prozac immediately. Gradually, the panic attacks stopped.

3

Patient Review

3/16/2022

Prozac for Depression

The medication was effective in that it helped me to relax; however, it did so to an extreme. I found myself unable to get upset about things that would normally bother me, and others commented that I seemed like a "robot" or "zombie." I stopped taking the medication after a month because I felt like it was numbing my emotions too much.

2.7

Patient Review

11/9/2022

Prozac for Depression

Prozac completely disconnected me from my body and reality. It was like being hypnotized and in a trance, akin to the "sunken place" scene in Get Out. I strongly advise against this medication unless you have severe PTSD and no responsibilities.

2.3

Patient Review

5/1/2022

Prozac for Posttraumatic Stress Syndrome

I have panic disorder and starting this medication was really tough because of the intense side effects. I tried different doses (10mg, 20mg, 30mg, 40mg) but none of them felt worth it to me. Yes, the panic stopped, but now I feel lifeless and like I can't enjoy intimacy anymore.

2

Patient Review

8/11/2022

Prozac for Depression

Prozac did nothing to alleviate my depression and actually made me more irritable. Once I stopped taking it, the withdrawals were terrible despite my doctor telling me there would be none.

1.7

Patient Review

4/2/2022

Prozac for Depression

My daughter was prescribed Prozac a week and a half ago, but it made her feel worse. So much so that she attempted suicide this past weekend. We've now experienced the negative effects of Prozac firsthand.

1.7

Patient Review

9/24/2022

Prozac for Obsessive Compulsive Disorder

I tried this drug for my sexual intrusive thoughts, as prescribed by my doctor, but saw zero improvement even after increasing the dosage. If anything, my anxiety and thoughts got worse while taking it. I'm now on a different medication (anafranil) and would not recommend this drug to anyone.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about prozac

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does Prozac do for a person?

"Fluoxetine, commonly known by the brand name Prozac, is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It is generally considered safe and effective for treating depression, anxiety, OCD, and bulimia. However, some people may experience increased suicidal thoughts."

Answered by AI

What are the side effects of taking Prozac?

"You may experience nausea, drowsiness, dizziness, anxiety, trouble sleeping, loss of appetite, tiredness, sweating, or yawning while taking this medication. Keep in mind that your doctor prescribed this medication because they believe the benefits of it are greater than the risks of any potential side effects."

Answered by AI

How will Prozac make you feel?

"As Prozac begins to work, you may notice an increase in your energy levels. In some people, it may cause symptoms of mania, which include high energy levels, racing thoughts, trouble sleeping, and irritability."

Answered by AI

Is Prozac a happy pill?

"The original "happy pill” Prozac was approved for use in 1987. It was the first drug prescribed and marketed on a large scale for the treatment of depression. The use of Prozac is very common, but it is not without its risks."

Answered by AI

How does Prozac make you feel?

"As Prozac begins to take effect, you may notice an increase in your energy levels. In some cases, it may cause symptoms of mania in some people taking this medication. Symptoms of mania include high energy levels, racing thoughts, trouble sleeping, and irritability."

Answered by AI

What is a major side effect of Prozac?

"The following effects may occur: nausea, drowsiness, dizziness, anxiety, trouble sleeping, loss of appetite, tiredness, sweating, or yawning. If you experience any of these effects for an extended period of time, or if they worsen, tell your doctor."

Answered by AI

Clinical Trials for Prozac

Image of University of California at San Diego (UCSD) in San Diego, United States.

Neuronavigated aiTBS for Depression

18 - 65
All Sexes
San Diego, CA

The purpose of this study is to confirm the efficacy of two recently introduced repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation - in treatment-resistant depression (TRD). Using a three-arm design (neuronavigated aiTBS, non-neuronavigated aiTBS, and sham), this randomized controlled trial (RCT) is the first to specifically investigate the incremental benefit of neuronavigation within an accelerated stimulation protocol, as well as the first confirmatory RCT comparing the efficacy of each of these active treatments vs. sham, overcoming previous generalizability issues and being conducted in an independent, multicenter US TRD sample.

Waitlist Available
New This Month

University of California at San Diego (UCSD) (+2 Sites)

Image of Wahwala Iyohlogya/Peaceful Means in Pine Ridge, United States.

Lakota Family Acceptance Program for Depression and Anxiety

Any Age
All Sexes
Pine Ridge, SD

The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their caregivers. The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. We will also examine pre- to post- changes on outcomes for the sole purposes of making sure scores on measures are changing in the hypothesized direction (e.g., depression scores are going from moderate to minimal as opposed to no change or depression scores increasing). Once enrolled in the study, participants complete a baseline survey. Then they will participate in LFAP which is an 8-session group intervention; sessions will be scheduled once a week for eight weeks (at 2 hours per session). Participants will complete survey instruments before and immediately after the program sessions, in addition to post-program surveys and an exit interview.

Recruiting
Has No Placebo

Wahwala Iyohlogya/Peaceful Means (+1 Sites)

Katie Edwards, PhD

Image of Seaway Valley Community Health Centre (Cardiac Rehab Program) in Cornwall, Canada.

FRAME for Heart Failure

18+
All Sexes
Cornwall, Canada

Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.

Recruiting
Has No Placebo

Seaway Valley Community Health Centre (Cardiac Rehab Program) (+8 Sites)

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Image of UCLA Semel Institute in Los Angeles, United States.

Psilocybin-assisted CBT for Depression

21 - 60
All Sexes
Los Angeles, CA

The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. This study is a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to PA-CBT. Both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). In Phase II, participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).

Phase 1 & 2
Recruiting

UCLA Semel Institute

Image of University of Rochester Medical Center in Rochester, United States.

Deaf CBT-TS for Suicide Risk

18+
All Sexes
Rochester, NY

The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are: * Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors? * Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use? * Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress? * Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors. Participants will: * Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment. * Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months * Complete two follow-up assessments in 2 and 4 months.

Waitlist Available
Has No Placebo

University of Rochester Medical Center

Image of Sunwise Clinical Research /ID# 277555 in Walnut Creek, United States.

Icalcaprant for Depression

18 - 65
All Sexes
Walnut Creek, CA

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to placebo treatment. Around 195 adult participant with major depressive disorder will be enrolled in approximately 35 sites in North America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Phase 2
Recruiting

Sunwise Clinical Research /ID# 277555 (+7 Sites)

ABBVIE INC.

AbbVie

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Image of St. Joseph's Healthcare Hamilton in Hamilton, Canada.

Psychotherapy for Depression

18 - 65
Female
Hamilton, Canada

The RESPOND trial explores the link between early life adversity and later life depressive symptoms. The investigators have designed a new psychological therapy tailored to address the symptoms that can be caused by difficult experiences in early life. These symptoms include low mood, emotional dysregulation, and distressing thoughts and beliefs related to difficult or traumatic experiences. The investigators would like to see if this new therapy helps people feel better. The investigators are also studying the biological changes that can occur as a result of early life adversity, and how this therapy may influence those changes. To do this, The investigators ask questions about participants' physical and mental health and take blood samples.

Recruiting
Has No Placebo

St. Joseph's Healthcare Hamilton

Sheryl Green, PhD

Image of University of Rochester Medical Center in Rochester, United States.

Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression

18+
All Sexes
Rochester, NY

The goal of this clinical trial is to understand the effect of ketamine on the brain in people with treatment-resistant depression (TRD). TRD occurs in around a third of people with depression and leads to higher suicide rates compared to those with major depressive disorder. A desperate need for a rapid acting antidepressant drug (RAAD) is needed to help improve quality of life for people with TRD. Ketamine has been shown to be a RAAD, and esketamine (a form of ketamine) was approved by the FDA to treat TRD. Ketamine has been known to cause dissociative experiences, that can lead to an increase in the "Openness to Experience" personality trait and psychological flexibility that occurs at "peak experience". This has been shown to improve mental health conditions and lower suicide risk. This study aims to further understand if there is a connection between this new change of mind and changes in brain activity. Ketamine has been shown to improve brain plasticity as well, specifically in the frontolimbic region of the brain, an area associated with depression. The investigators are analyzing the brain using functional magnetic resonance imaging (fMRI), a method used to measure brain activity. The frontolimbic region is also associated with cognitive flexibility and emotional processing, an important hurdle in treating TRD. Due to this, the investigators are pairing the ketamine treatment with psychotherapy sessions, to guide the processing experience, which can lead to higher emotional flexibility. The main questions this study aims to answer are: * Are frontolimibic plasticity circuitry changes associated with openness to experience and peak experience? * Is it feasible to recruit and retain people through a two-month KAP study? * Is the structure of the study effective for treating TRD? Participants will: * Visit the facilities 6-8 times * Complete 2 MRI brain scans * Complete 3-4 psychotherapy sessions * Receive 1-2 doses of ketamine * Complete online surveys between 3-4 visits

Phase 2
Waitlist Available

University of Rochester Medical Center

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