CLINICAL TRIALS PROFILE FOR SERTRALINE HYDROCHLORIDE

All Clinical Trials for sertraline hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000378 ↗	Antidepressant Treatment of Melancholia in Late Life	Completed	National Institute of Mental Health (NIMH)	Phase 4	1997-07-01	The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.
NCT00000378 ↗	Antidepressant Treatment of Melancholia in Late Life	Completed	New York State Psychiatric Institute	Phase 4	1997-07-01	The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.
NCT00000384 ↗	Treatment of Obsessive-Compulsive Disorder (OCD) in Children	Completed	National Institute of Mental Health (NIMH)	Phase 3	1997-05-01	The purpose of this study is to compare 3 treatments for children with OCD: medication (sertraline, SER) alone vs OCD-specific therapy (Cognitive Behavior Therapy, CBT) vs medication plus therapy. Some patients will receive an inactive placebo (PBO) instead of medication and/or Educational Support (ES, non-psychological treatment) instead of therapy. One in 200 children suffer from OCD, but few receive appropriate treatment. Both CBT and medication seem to be effective, but their effectiveness, alone and in combination, has not been evaluated. There are 2 phases to this trial. In Phase I the child will receive 1 of the following 6 treatments for 12 weeks: 1) SER alone; 2) pill PBO alone; 3) CBT alone; 4) SER plus CBT; 5) SER plus ES; 6) pill PBO plus ES. If the child responds to treatment, he/she will go on to Phase II in which the treatment will be slowly reduced, then stopped (discontinued), over time to test the treatment's durability. The child will be evaluated at Weeks 1, 4, 8, 12 (Phase I treatment), and Weeks 16, 20, 24, and 28 (Phase II discontinuation) to see how effective and durable the treatment is in treating your child's OCD. A child may be eligible for this study if he/she: Has obsessive-compulsive disorder (OCD) and is 8 - 16 years old.
NCT00000321 ↗	Methamphetamine Abuse Treatment in Patients With AIDS - 1	Completed	Friends Research Institute, Inc.	Phase 4	1996-10-01	The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.
NCT00000321 ↗	Methamphetamine Abuse Treatment in Patients With AIDS - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 4	1996-10-01	The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.

Clinical Trial Conditions for sertraline hydrochloride

Condition Name

Condition Name for sertraline hydrochloride
Intervention	Trials
Depression	76
Major Depressive Disorder	38
Healthy	17
Post-Traumatic Stress Disorder	12

Condition MeSH

Condition MeSH for sertraline hydrochloride
Intervention	Trials
Depression	154
Depressive Disorder	133
Depressive Disorder, Major	70
Disease	69

Clinical Trial Locations for sertraline hydrochloride

Trials by Country

+

−

Trials by Country for sertraline hydrochloride
Location	Trials
United States	521
Canada	43
Japan	20
Brazil	17
Australia	14

Trials by US State

+

−

Trials by US State for sertraline hydrochloride
Location	Trials
New York	46
California	36
Pennsylvania	33
Texas	31
Massachusetts	30

Clinical Trial Progress for sertraline hydrochloride

Clinical Trial Phase

Clinical Trial Phase for sertraline hydrochloride
Clinical Trial Phase	Trials
Phase 4	108
Phase 3	54
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for sertraline hydrochloride
Clinical Trial Phase	Trials
Completed	218
Terminated	36
Unknown status	26

Clinical Trial Sponsors for sertraline hydrochloride

Sponsor Name

Sponsor Name for sertraline hydrochloride
Sponsor	Trials
National Institute of Mental Health (NIMH)	53
Pfizer	29
Duke University	13

Sponsor Type

Sponsor Type for sertraline hydrochloride
Sponsor	Trials
Other	436
Industry	112
NIH	91

Sertraline Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Sertraline hydrochloride, commonly known by the brand name Zoloft, is a selective serotonin reuptake inhibitor (SSRI) widely used for the treatment of various mental health conditions, including depression, post-traumatic stress disorder (PTSD), and dysthymia. This article provides an update on recent clinical trials, market analysis, and future projections for sertraline hydrochloride.

Clinical Trials Update

Recent Trials on PTSD

One of the most significant recent developments involves the combination of brexpiprazole and sertraline for the treatment of post-traumatic stress disorder (PTSD). Otsuka Pharmaceutical and H. Lundbeck A/S have announced that the FDA has accepted their supplemental new drug application (sNDA) for this combination therapy. The trials, which include three randomized clinical studies, showed that the combination of brexpiprazole and sertraline was generally well-tolerated and associated with a statistically significant reduction in PTSD symptoms compared to sertraline plus placebo in two of the trials (Trials 061 and 071)[1].

Efficacy and Safety

The primary endpoint in these trials was the change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from randomization to Week 10. The results indicated improvements across various symptom clusters, including re-experiencing, avoidance, negative cognition/mood, and arousal/reactivity symptoms. Although the primary endpoint was not met in Trial 072, the overall trend of symptom reduction was consistent with the other trials[1].

Market Analysis

Global Market Size and Growth

The global sertraline hydrochloride market has been growing steadily, driven by increasing demand, an expanding customer base, and technological advancements. The market size is projected to continue growing, with forecasts indicating a significant increase in value and volume over the next few years. For instance, the global sertraline hydrochloride market is expected to reach a substantial value by 2026, up from its 2020 levels, at a compound annual growth rate (CAGR) of a notable percentage during the 2021-2026 period[2].

Regional Market Dynamics

The market is segmented across various regions, including the United States, Europe, China, Japan, Southeast Asia, India, and Brazil. Each region has its own market dynamics, with different growth rates and market sizes. For example, the United States and Europe are among the leading markets due to high demand and advanced healthcare infrastructure. Emerging markets like China and India are also expected to contribute significantly to the global growth due to increasing healthcare spending and a growing patient population[5].

Competitive Landscape

The sertraline hydrochloride market is highly competitive, with several major players such as Pfizer, Teva Pharmaceutical Industries Ltd., Novartis AG, and Mylan. These companies are involved in various strategies including mergers, acquisitions, and new investments to maintain their market share and expand their reach. The competitive dynamics are further influenced by the presence of generic versions of sertraline, which have been introduced by companies like Apotex and Zydus[2][5].

Market Projections

Future Growth Potential

The sertraline hydrochloride market is expected to continue its growth trajectory due to several factors. Increasing awareness about mental health, expanding healthcare coverage, and the rising prevalence of mental health disorders are key drivers. Additionally, advancements in pharmacotherapy and the potential approval of new combination therapies, such as the brexpiprazole and sertraline combination for PTSD, are likely to boost market growth[1][5].

Market Size and Value Forecast

By 2025, the global sertraline hydrochloride market is projected to achieve significant growth in both volume and value. The market size is expected to increase due to higher consumption rates and increasing demand from various regions. The forecast also includes regional growth rates, with some regions expected to grow faster than others due to local market conditions and healthcare policies[5].

Price Trends and Revenue Forecast

The price trends for sertraline hydrochloride are expected to remain stable, with some fluctuations based on regional market conditions and the introduction of generic versions. The revenue forecast indicates a steady increase, driven by the growing demand and expanding market share of key players. The forecast also includes segment-wise revenue projections based on different types and applications of sertraline hydrochloride[5].

Key Applications and Indications

Depression and Dysthymia

Sertraline hydrochloride is widely used for the treatment of depression and dysthymia. Clinical trials have shown that it is effective in reducing depressive symptoms and improving the quality of life for patients. It is often compared to other SSRIs and has been found to be as effective as other treatments like imipramine in managing dysthymia[3].

Post-Traumatic Stress Disorder (PTSD)

Sertraline is approved for the treatment of PTSD and is recommended by various guidelines as a first-line pharmacological therapy. Meta-analyses have shown that sertraline is statistically superior to placebo in reducing PTSD symptoms, although the effect size is generally small[3].

Safety and Side Effects

General Safety Profile

Sertraline hydrochloride is generally well-tolerated, but like other SSRIs, it can have side effects such as nausea, headache, and sexual dysfunction. Clinical trials have shown that the combination of brexpiprazole and sertraline for PTSD is also well-tolerated, with a safety profile consistent with the individual components[1].

Suicidal Ideation and Behavior

There has been some concern regarding the risk of suicidal ideation and behavior associated with SSRIs, including sertraline. However, comprehensive analyses by regulatory bodies have indicated that while there is a slight increase in risk, it is not statistically significant in most cases, and the overall benefit of the medication often outweighs the risks[3].

Key Takeaways

• Clinical Trials: The combination of brexpiprazole and sertraline for PTSD has shown promising results in recent clinical trials, with potential for FDA approval by February 2025.
• Market Growth: The global sertraline hydrochloride market is expected to grow significantly, driven by increasing demand, technological advancements, and expanding healthcare coverage.
• Regional Dynamics: The market is segmented across various regions, with the United States and Europe being key markets and emerging markets like China and India showing high growth potential.
• Competitive Landscape: The market is highly competitive with major players like Pfizer, Teva, and Novartis, and is influenced by the presence of generic versions.
• Future Projections: The market is projected to achieve significant growth in both volume and value by 2025, driven by increasing awareness about mental health and advancements in pharmacotherapy.

FAQs

What is the current status of the brexpiprazole and sertraline combination for PTSD?

The FDA has accepted the sNDA for the brexpiprazole and sertraline combination for PTSD, with a target action date of February 8, 2025[1].

How effective is sertraline hydrochloride in treating depression?

Sertraline hydrochloride is as effective as other SSRIs in treating depression, with meta-analyses showing an odds ratio for response in clinical depression between 1.44 and 1.67[3].

What are the common side effects of sertraline hydrochloride?

Common side effects include nausea, headache, and sexual dysfunction. The combination of brexpiprazole and sertraline has been found to be generally well-tolerated in clinical trials[1][3].

Which regions are expected to drive the growth of the sertraline hydrochloride market?

The United States, Europe, China, and India are expected to be key drivers of the market growth due to high demand and expanding healthcare infrastructure[5].

What is the projected market size of sertraline hydrochloride by 2026?

The global sertraline hydrochloride market is projected to reach a substantial value by 2026, up from its 2020 levels, at a notable CAGR during the 2021-2026 period[2].

Sources

1. Otsuka and Lundbeck Announce FDA Acceptance of sNDA Filing for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with PTSD. Otsuka Pharmaceutical, June 25, 2024.
2. Sertraline Hcl Market Generated Opportunities, Future Scope 2024-2031. OpenPR, December 17, 2024.
3. Sertraline. Wikipedia.
4. Sertraline Hydrochloride - Drug Targets, Indications, Patents. Synapse.
5. Global Sertraline Hydrochloride Consumption Market Research Report 2013-2025. Maia Research.