CLINICAL TRIALS PROFILE FOR SARAFEM

All Clinical Trials for Sarafem

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00339079 ↗	Treatment of Hypochondriasis With CBT and/or SSRI	Completed	National Institute of Mental Health (NIMH)	Phase 1/Phase 2	2006-06-01	This study will compare the effectiveness of cognitive behavioral therapy, antidepressant medication, and a combination of the two for treating hypochondriasis.
NCT00339079 ↗	Treatment of Hypochondriasis With CBT and/or SSRI	Completed	Brigham and Women's Hospital	Phase 1/Phase 2	2006-06-01	This study will compare the effectiveness of cognitive behavioral therapy, antidepressant medication, and a combination of the two for treating hypochondriasis.
NCT00678574 ↗	The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	1998-03-01	The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.
NCT00678574 ↗	The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder	Completed	University of Pennsylvania	Phase 4	1998-03-01	The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.
NCT01174394 ↗	Electroacupuncture Combined With Antidepressants for Post-stroke Depression	Completed	Kowloon Hospital, Hong Kong	N/A	2010-05-01	This is a randomized, assessor-blind, placebo controlled study in post stroke depression patients. Subjects receiving antidepressant drug would be assigned to either active or placebo scalp electro-acupuncture treatment, on the hypothesis that acupuncture intervention combined with antidepressants could produce greater therapeutic effects than antidepressants alone.

Clinical Trial Conditions for Sarafem

Condition Name

Condition Name for Sarafem
Intervention	Trials
Major Depressive Disorder	4
Healthy Subjects	2
Depression	2
Hypochondriasis	1

Condition MeSH

Condition MeSH for Sarafem
Intervention	Trials
Depressive Disorder	5
Depression	5
Depressive Disorder, Major	4
Disease	3

Clinical Trial Locations for Sarafem

Trials by Country

Trials by Country for Sarafem
Location	Trials
United States	5
Hong Kong	2
Japan	2
China	1

Trials by US State

Trials by US State for Sarafem
Location	Trials
New York	2
Georgia	1
Connecticut	1
Massachusetts	1

Clinical Trial Progress for Sarafem

Clinical Trial Phase

Clinical Trial Phase for Sarafem
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Sarafem
Clinical Trial Phase	Trials
Completed	8
Terminated	2

Clinical Trial Sponsors for Sarafem

Sponsor Name

Sponsor Name for Sarafem
Sponsor	Trials
Eli Lilly and Company	2
National Institute of Mental Health (NIMH)	2
Torrent Pharmaceuticals Limited	2

Sponsor Type

Sponsor Type for Sarafem
Sponsor	Trials
Other	11
Industry	4
NIH	2

Clinical Trials and Efficacy of SARAFEM

Overview of SARAFEM

SARAFEM, the brand name for fluoxetine when prescribed for Premenstrual Dysphoric Disorder (PMDD), has undergone several clinical trials to establish its efficacy and safety.

Clinical Trials for PMDD

The effectiveness of SARAFEM in treating PMDD was established through three placebo-controlled trials. These trials included one intermittent dosing trial and two continuous dosing trials. In the intermittent dosing trial, patients met the Diagnostic and Statistical Manual-4th edition (DSM-IV) criteria for PMDD. The continuous dosing trials were based on the Diagnostic and Statistical Manual-3rd edition revised (DSM-IIIR) criteria for Late Luteal Phase Dysphoric Disorder (LLPDD), which is now referred to as PMDD in the DSM-IV[1][4].

Key Findings

• Efficacy: Both the 20 mg and 60 mg doses of SARAFEM were proven effective in treating PMDD. However, there was no statistically significant added benefit for the 60 mg/day dose compared to the 20 mg/day dose[4].
• Duration of Treatment: The efficacy of SARAFEM was maintained for up to 6 months with continuous dosing and up to 3 months with intermittent dosing at a dose of 20 mg/day[4].
• Side Effects: Common adverse reactions included changes in appetite and weight, anxiety, nervousness, and insomnia. These side effects were associated with treatment discontinuation in some cases[4].

Safety Considerations

• Seizures: No patients treated with SARAFEM in the PMDD clinical trials reported seizures. However, patients with a history of seizures should be treated with caution[1][4].
• Serotonin Syndrome: There is a potential increased risk for serotonin syndrome when SARAFEM is used concomitantly with other serotonergic agents. Patients should be monitored closely, and treatment should be discontinued if symptoms of serotonin syndrome occur[4].

Market Analysis and Projections for SARAFEM and Fluoxetine

Market Growth Drivers

The market for fluoxetine, including SARAFEM, is driven by several key factors:

Increasing Prevalence of Mental Health Disorders

The rise in the prevalence of mental health disorders such as depression, obsessive-compulsive disorder, and bulimia nervosa is a significant driver for the fluoxetine market. Fluoxetine, being a selective serotonin reuptake inhibitor (SSRI), is widely prescribed for these conditions[3].

Expanding Telehealth Services

The growth of telehealth services, including telepsychiatry, has made mental health care more accessible. This increased accessibility is expected to drive the demand for antidepressants like fluoxetine[2].

Generic Options and Affordability

The availability of generic antidepressants enhances the accessibility and affordability of these medications, contributing to market growth. This is particularly beneficial in both established and emerging markets[2].

Market Projections

Global Antidepressant Market

The global antidepressant drugs market is expected to grow significantly. By 2033, this market is projected to reach a revenue of USD 26.9 billion from 2025, with a compound annual growth rate (CAGR) of 3.3%. The SSRIs segment, which includes fluoxetine, is anticipated to dominate this market[2].

Fluoxetine Market

The global fluoxetine market is expected to grow at a CAGR of 4.10% from 2022 to 2029. This growth is driven by factors such as the increasing geriatric population, rising healthcare expenditure, and growing government initiatives to improve mental health care[3].

Regional Analysis

North America is expected to dominate the antidepressant drugs market, capturing a 47.9% revenue share in 2024. The high occurrence of anxiety and depression in this region, along with a strong healthcare infrastructure and advanced research facilities, supports this dominance. The Asia-Pacific region is expected to experience the fastest growth due to economic, social, and lifestyle changes, as well as an aging population[2].

Distribution Channels

Hospital pharmacies are expected to have the largest revenue share in the antidepressant drugs market, including fluoxetine. Retail pharmacies and online pharmacies also play significant roles, especially with the rise in telehealth services and the convenience of online shopping[2][3].

Challenges and Limitations

Side Effects and Stigma

Despite the market growth, the side effects associated with fluoxetine, such as loss of appetite, diarrhea, headache, nausea, dizziness, and seizures, can hamper market growth. Additionally, the stigma surrounding mental health may impact treatment adherence and seeking behavior[2][3].

Lack of Awareness and Competition

Lack of awareness about mental health and the intense competition among market players are other challenges that the fluoxetine market faces. These factors can limit the market's potential growth[3].

Key Takeaways

• Clinical Efficacy: SARAFEM has been proven effective in treating PMDD through several clinical trials.
• Market Growth: The fluoxetine market is expected to grow driven by increasing prevalence of mental health disorders, expanding telehealth services, and the availability of generic options.
• Regional Dominance: North America is expected to dominate the market, with the Asia-Pacific region showing the fastest growth.
• Challenges: Side effects, stigma surrounding mental health, lack of awareness, and competition among market players are significant challenges.

FAQs

What is SARAFEM used for?

SARAFEM is the brand name for fluoxetine when it is prescribed for the treatment of Premenstrual Dysphoric Disorder (PMDD).

What are the common side effects of SARAFEM?

Common side effects include changes in appetite and weight, anxiety, nervousness, insomnia, and in some cases, seizures and allergic reactions.

How effective is SARAFEM in treating PMDD?

SARAFEM has been proven effective in treating PMDD through several placebo-controlled clinical trials, with both 20 mg and 60 mg doses showing efficacy.

What is the projected market growth for fluoxetine?

The global fluoxetine market is expected to grow at a CAGR of 4.10% from 2022 to 2029, driven by increasing prevalence of mental health disorders and other factors.

Which region dominates the antidepressant drugs market?

North America is expected to dominate the antidepressant drugs market, capturing a 47.9% revenue share in 2024.

Sources

1. Drugs.com: Sarafem: Package Insert / Prescribing Information.
2. GlobeNewswire: Antidepressant Drugs Market is expected to reach a revenue of USD 26.9 billion by 2033.
3. Data Bridge Market Research: Global Fluoxetine Market - Industry Trends and Forecast to 2029.
4. FDA: SARAFEM Label.
5. Grand View Research: Post-traumatic Stress Disorder Treatment Market Report 2030.