Sarafem

Premature Ejaculation, Cataplexy, Bulimia Nervosa + 11 more

Treatment

6 FDA approvals

20 Active Studies for Sarafem

What is Sarafem

Fluoxetine

The Generic name of this drug

Treatment Summary

Fluoxetine is an antidepressant medication approved by the FDA in 1987. It belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs) and is commonly prescribed to treat depression, as well as other mental disorders.

Prozac

is the brand name

image of different drug pills on a surface

Sarafem 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 Sarafem Affects Patients

Fluoxetine is an antidepressant that works by keeping serotonin levels high in certain parts of the brain. It doesn't interact strongly with other brain receptors which is why it has fewer side effects than other types of antidepressants.

How Sarafem works in the body

Fluoxetine is a medicine used to treat depression. It works by increasing the amount of serotonin in the brain. Serotonin is a chemical that helps to regulate mood. Fluoxetine specifically blocks the reuptake of serotonin, which makes more of it available to the brain. Fluoxetine also interacts with a certain kind of receptor, which helps to increase the levels of noradrenaline and dopamine in the brain as well. This helps to improve mood and reduce symptoms of depression.

When to interrupt dosage

The amount of Sarafem is contingent upon the diagnosed affliction, including Myoclonus, Bipolar Disorder and Unipolar Depression. The dosage also relies on the method of delivery (e.g. Tablet, coated or Oral) featured in the table beneath.

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

Sarafem has five counter-indications and should not be engaged with when encountering any of the conditions outlined in the following table.

Sarafem 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 Sarafem.

Common Sarafem 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.

Sarafem Toxicity & Overdose Risk

In most cases, symptoms related to overdosing on fluoxetine are mild and short-lived, including drowsiness, shaking, fast heart rate, nausea, and vomiting. It is recommended to provide supportive care in these cases. However, more severe symptoms have been reported in cases where fluoxetine was taken with other drugs or substances. These can include seizures, signs of serotonin syndrome, and muscle breakdown. In one case, a patient who took 1400mg of fluoxetine had a seizure 3 hours later. Another patient who took 1.2g of fluoxetine experienced seizures and other serious symptoms.

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

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

881 active studies are currently investigating the capacity of Sarafem to alleviate Disease, Anorexia Nervosa and serve as 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

Sarafem Reviews: What are patients saying about Sarafem?

5

Patient Review

2/23/2010

Sarafem for Premenstrual Disorder with a State of Unhappiness

I was really pleased with how well Sarafem worked for me, but my pharmacist told me it's been discontinued. Do any other treatments work as well?

5

Patient Review

4/25/2012

Sarafem for Premenstrual Disorder with a State of Unhappiness

I lost weight while taking this drug, even though I had no appetite.

5

Patient Review

4/11/2017

Sarafem for Premenstrual Disorder with a State of Unhappiness

I took this medication many years ago and it was a complete game-changer for me. I experienced much more calm while dealing with my monthly period and found that I didn't make as many bad decisions because of the drama associated with it. I'm disappointed that doctors now don't seem to know about this medication and that it may have been discontinued. If it works, which it did for me, then it should be available to those who need it.

5

Patient Review

1/2/2010

Sarafem for Premenstrual Disorder with a State of Unhappiness

I am currently researching Sarafem. All reviews have been very helpful. I am feeling tense, overwhelmed, and angry. I have an appointment with the doctor tomorrow, and I am hoping to find some relief from these symptoms!

5

Patient Review

10/31/2013

Sarafem for Bipolar Depression

I only used this treatment for a short while, but I definitely noticed a difference in my depression and PMDD. Agitation levels decreased significantly and I felt well enough to get out of bed after a week of being depressed.

5

Patient Review

1/6/2010

Sarafem for Premenstrual Disorder with a State of Unhappiness

This treatment has helped me in the past, and I hope it will continue to be effective.

5

Patient Review

12/26/2009

Sarafem for Posttraumatic Stress Syndrome

This medication has been very helpful to me.

5

Patient Review

11/9/2009

Sarafem for Premenstrual Disorder with a State of Unhappiness

5

Patient Review

12/10/2009

Sarafem for Premenstrual Disorder with a State of Unhappiness

4.7

Patient Review

6/10/2010

Sarafem for Premenstrual Disorder with a State of Unhappiness

I found that this drug helped to stabilize my mood and make me less irritable in the two weeks leading up to my period. It's been a total game-changer for me, and I would definitely recommend it to other women who deal with similar issues.

4

Patient Review

7/25/2019

Sarafem for Anxiousness associated with Depression

Many doctors won't tell women this, but Sarafem is Prozac. They're the exact same drug; they just changed the name because of prozac's reputation as being for "crazy people." Its actual use was for depression, so I switched from prozac to sarafem for that reason. I didn't want people judging me based on the bottle. Just wanted to make sure all of you were aware of this.

3.7

Patient Review

5/17/2010

Sarafem for Premenstrual Disorder with a State of Unhappiness

I've been taking Sarafem for quite a while now, and it hasn't worked very well for me. I have a pretty bad case of depression, and some people don't believe me when I say that this drug doesn't work. My doctor said she would put me on a stronger dosage, but she never did. If you're struggling with extreme depression, ask your doctor for a higher dose. The initial dosage probably won't help if you only have mild depression.

3.7

Patient Review

7/22/2011

Sarafem for Premenstrual Disorder with a State of Unhappiness

This medication has helped me slim down and feel more relaxed day-to-day.

3.3

Patient Review

1/25/2010

Sarafem for Bipolar Depression

This treatment is simple to take and really does help with my severe PMDD. It keeps my moods stable and also helps with the severity of my PMDD symptoms.

2

Patient Review

3/26/2012

Sarafem for Anorexia Nervosa

Sarafem did help take the edge off of my PMS symptoms, however I found it very difficult to sleep while taking it. Additionally, I was unable to orgasm which was a big issue for me. Overall, I would not recommend this medication.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about sarafem

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

What is the generic for Sarafem?

"Fluoxetine is used to treat= Fluoxetine is effective for treating depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder)."

Answered by AI

Is Sarafem discontinued?

"If you are looking for Sarafem, you should know that the prices and coupons for the 1 dose pack (20mg) of Sarafem 28 tablets is no longer available because the manufacturer has discontinued this form and dosage."

Answered by AI

Is Sarafem same as Prozac?

"For patients with PMDD, Prozac is available under the brand name Sarafem, which is simply Prozac in pill form. For those who cannot take pills, Prozac is also available in liquid form. Most people will need to take the medication for 3-4 weeks to experience optimal results."

Answered by AI

Is Sarafem used for PMDD?

"The FDA has approved Sarafem for the treatment of premenstrual dysphoric disorder, a severe form of premenstrual syndrome. Sarafem is the equivalent of Prozac, which is used to treat depression, obsessive-compulsive disorder, and bulimia."

Answered by AI

Clinical Trials for Sarafem

Image of NewYork-Presbyterian Hospital / Weill Cornell Medicine in New York, United States.

Exposure and Response Prevention Therapy for Obsessive-Compulsive Disorder

10 - 17
All Sexes
New York, NY

The goal of this clinical trial is to learn whether brain scan results can help predict and track changes in obsessive-compulsive disorder, or OCD, symptoms in children and teens ages 10 to 17 who receive Exposure and Response Prevention therapy, also called ERP. ERP is a type of therapy in which participants practice facing OCD-related fears while resisting rituals or compulsions. The main question this study aims to answer is: Can each participant's pattern of brain connections, measured with functional MRI brain scans, help predict and track weekly changes in OCD symptoms during and after a 14-week course of ERP, including during planned monthly booster sessions and additional booster sessions offered if symptoms worsen? All participants will receive ERP. There is no placebo and no comparison group. Participants will: * Complete screening, consent or assent, interviews, questionnaires, and MRI safety checks * Receive 14 weekly ERP sessions * Complete OCD symptom assessments and functional MRI brain scans before, during, and after ERP * Receive planned monthly ERP booster sessions after the 14 weekly sessions * Receive additional brief ERP booster sessions if OCD symptoms worsen during follow-up * Take part for up to about 62 weeks

Waitlist Available
Has No Placebo

NewYork-Presbyterian Hospital / Weill Cornell Medicine

Conor Liston, MD, PhD

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We made a collection of clinical trials featuring Sarafem, we think they might fit your search criteria.
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Image of Pennsylvania Hospital in Philadelphia, United States.

Electroconvulsive Therapy for Depression

Any Age
All Sexes
Philadelphia, PA

The goal of this clinical trial is to improve how electroconvulsive therapy (ECT) stimulation settings are chosen. Researchers will use real-time brain monitoring to measure both seizures and a recently identified brain event called cortical spreading depolarization (CSD). The main questions it aims to answer are: What is the best way to increase ECT stimulation settings? How do different pulse settings affect the brain's response? Can certain settings produce CSD without causing a seizure? Participants already receiving ECT as part of their care will take part. They will be assigned to one of two groups: Index ECT group: Participants starting ECT will receive different standard titration approaches. Maintenance ECT group: Participants receiving ongoing ECT will undergo a brief, low-dose stimulation test before treatment. All participants will be monitored using brain physiology (EEG and blood flow) and symptom scales during treatment.

Waitlist Available
Has No Placebo

Pennsylvania Hospital

Image of McLean Hospital in Belmont, United States.

Theta Burst Stimulation for Depression

18+
All Sexes
Belmont, MA

Many people with depression do not get better with standard treatments like medication. One promising alternative is transcranial magnetic stimulation (TMS), a non-invasive procedure that uses magnetic pulses to stimulate specific brain regions. A particular pattern of TMS called continuous theta-burst stimulation (cTBS) is thought to reduce overactive brain activity in depression, but we do not yet fully understand how it works at the level of brain cells and connections. This study aims to determine the biological mechanism by which cTBS changes brain activity in people with depression. Specifically, we are testing two competing ideas: (1) that cTBS works by weakening the connections between brain cells through a process called long-term depression (LTD), which is driven by a chemical messenger system called glutamate; or (2) that cTBS works by increasing the brain's natural "braking" system, driven by a different chemical messenger called GABA. To test these ideas, participants with depression will receive cTBS along with one of four FDA-approved medications, or placebo, that either boost or block these chemical messenger systems. We will measure changes in brain activity using electroencephalography (EEG) recorded simultaneously with TMS. Specific patterns in the EEG signal, called TMS-evoked potentials (TEPs), act as a window into how different brain cell types are responding to stimulation. Each participant will complete four study visits, each testing a different drug-TMS combination in random order. One group of participants will test drugs targeting the glutamate system (d-cycloserine and memantine). A second group will test drugs targeting the GABA system (lorazepam and baclofen). All drugs are given as a single oral dose and are commonly used in clinical practice. Understanding exactly how cTBS works at a biological level could open the door to more effective, personalized TMS treatments.

Phase < 1
Recruiting

McLean Hospital

Joshua C Brown, MD, PhD

Image of Wake Forest University Health Sciences in Winston-Salem, United States.

Auditory Stimulation for Insomnia

20 - 50
All Sexes
Winston-Salem, NC

The goal of this clinical trial is to determine if alpha phase-locked auditory stimulation can improve sleep in people with insomnia and depression. The main goals of the pilot study are the following: Determine whether alpha phase-locked auditory stimulation (active stimulation) improves objective and subjective sleep in individuals with insomnia and depression. The study team hypothesizes that active auditory stimulation will reduce objective and subjective sleep onset latency (SL) and wake after sleep onset (WASO) compared to a sham stimulation. Participants will: * Wear Elemind Neuromod headband nightly for 4 weeks (1 week baseline, 1 week active/sham stimulation, 1 week washout, and 1 week opposite condition - active/sham stimulation) * Wear actigraphy watch for duration of the study * Complete questionnaires regarding their sleep, mood, and satisfaction with the device

Waitlist Available
New This Month

Wake Forest University Health Sciences

Ruth Benca, MD, PhD

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We made a collection of clinical trials featuring Sarafem, we think they might fit your search criteria.
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Image of Brown University in Providence, United States.

Mindfulness-Based Intervention for Mental Health

18 - 24
All Sexes
Providence, RI

The goal of this clinical trial (single-arm feasibility study) is to examine the feasibility, acceptability, and preliminary efficacy of a mindfulness-based, app-delivered intervention to address mental health and emotion regulation challenges in young adults with early life adversities (ELAs). The main questions it aims to answer is: \- Will young adults find the Growth, Empowerment, and Mindfulness (GEM) intervention to be both feasible and acceptable, as demonstrated by participants' engagement and quantitative/qualitative feedback? Additionally, it aims to answer: * Will GEM intervention demonstrate preliminary efficacy in improving outcome measures including depression, anxiety? * Are improvements in mindfulness and sleep, as well as reductions in rumination, mechanisms of action underlying the improvements in psychological and behavioral outcomes of the intervention? Participants will be asked to: * participate in GEM, which integrates app-based intervention content, formal and informal mindfulness practices, weekly Zoom group sessions, and ecological momentary intervention (EMI) delivery * complete baseline, post-intervention, and 3-month follow-up assessments * complete weekly assessments and daily ecological momentary assessments (EMAs) during the intervention delivery * wear Fitbit for researchers to collect sleep-related data

Recruiting
Has No Placebo

Brown University

Shufang Sun, PhD

Image of Biomedical Research Imaging Center (BRIC) at UNC in Chapel Hill, United States.

Kurvelo for Irritability in Adolescents

12 - 16
Female
Chapel Hill, NC

Purpose: Risk of severe psychopathology increases dramatically during adolescence, especially for females. Changes in ovarian steroids across the menstrual cycle produce windows of vulnerability to mood disturbances, particularly during the abrupt withdrawal of estradiol (E2) and progesterone (P4) prior to menses onset. Irrefutable evidence links stress with affective symptoms, potentially mediated by E2-related modifications of frontolimbic connectivity and prefrontal gamma-aminobutyric acid (GABA) inhibitory signaling. The primary objective of this project is to empirically test the impact of E2 and P4 change on vulnerable brain networks associated with irritability and other depressive symptoms in female adolescents at risk of suicide. Participants: The investigators will enroll 50 female adolescents ages 12-16 who are at risk of suicide (i.e., moderate depressive symptoms), and are eligible to receive oral contraceptives and undergo MRI imaging. Procedure: Using a randomized, placebo-controlled, cross-over design, participants will be studied under two conditions: 8 weeks of E2 and P4 stabilization (continuous combined oral contraceptive (COC) to prevent perimenstrual withdrawal) and 8 weeks of placebo, with a 1-month washout after each condition. Each condition will include: 1) daily samples of E2 and P4 urinary metabolites, 2) daily symptom ratings(e.g., irritability, negative affect and suicidal thoughts and behaviors (STBs)), and 3) a neuroimaging session with MRI and magnetic resonance spectroscopy (MRS).

Phase 4
Waitlist Available

Biomedical Research Imaging Center (BRIC) at UNC (+1 Sites)

Elizabeth Andersen, PhD

Image of Michael E. DeBakey VA Medical Center, Houston, TX in Houston, United States.

Behavioral Activation-Guided Self-Help for Depression

18+
All Sexes
Houston, TX

Symptoms of depression are highly prevalent among Veterans. However, fewer than 30% of individuals with these symptoms receive any psychotherapy in the Veterans Health Administration (VHA). This is due to many factors, which may include provider availability and patient preferences. Guided self-help (GSH), which involves coaching sessions with patients who are following a fully developed self-help program, has the potential to increase access to care for these Veterans, particularly if implemented within a stepped care model of mental health treatment delivery and if delivered by a diverse set of providers. The VHA's primary care-mental health integration (PCMHI) service, which focuses on short courses of care for mild to moderate symptoms, may be an ideal place in which to deploy GSH. The current project seeks conduct a pilot randomized trial of a GSH program for depression adapted for PCMHI based on behavioral activation.

Waitlist Available
Has No Placebo

Michael E. DeBakey VA Medical Center, Houston, TX

Maribel Plasencia, BA MS PhD

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We made a collection of clinical trials featuring Sarafem, we think they might fit your search criteria.
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