CLINICAL TRIALS PROFILE FOR LEXAPRO

All Clinical Trials for LEXAPRO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00101452 ↗	Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression	Completed	National Center for Complementary and Integrative Health (NCCIH)	N/A	2005-04-01	The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.
NCT00101452 ↗	Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression	Completed	Maurizio Fava, MD	N/A	2005-04-01	The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.
NCT00105586 ↗	Drug Therapy for Generalized Anxiety Disorder Among the Elderly	Completed	National Institute of Mental Health (NIMH)	Phase 4	2004-12-01	This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD in elderly individuals.
NCT00086307 ↗	Lexapro and Pramipexole and to Treat Major Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	2004-06-01	This study compares the effectiveness of the combination of antidepressants: Lexapro and Pramipexole, with the effectiveness of each antidepressant alone. Purpose: Patients between 18 and 65 years of age with Major Depressive Disorder without psychotic features may be eligible for this 9-week study. Candidates must currently be in a major depressive episode of at least 4 weeks' duration, have failed to respond to treatment with an SSRI (Prozac, Zoloft, Paxil, Luvox, Celexa), and not have failed to respond to more than four antidepressants for the current episode. Candidates are screened with a physical examination, psychiatric evaluation, blood tests, review of vital signs, height and weight measurements, electrocardiogram (ECG), urine test for illegal drugs, and pregnancy test for women. Participants are tapered off antidepressants or other medications prohibited during the study and remain drug-free for 1 week before starting treatment. They are then randomly assigned to take pramipexole and escitalopram, pramipexole alone, or escitalopram alone for 6 weeks. During the study, participants come to the clinic eight times for health assessments and symptoms assessments, which include a check of vital signs and rating scales for depression and anxiety, adverse events, and sexual functioning. Blood and urine samples are collected periodically to monitor health, detect pregnancy in women, and detect illicit drug use. At the end of the 6-week treatment period, participants have a physical examination, ECG, blood test, and check of vital signs. Short-term anti-depressant treatment is offered, and plans are made for long-term treatment. Atendemos pacientes de habla hispana. ...
NCT00071643 ↗	Preventing Post-Stroke Depression	Completed	National Institute of Mental Health (NIMH)	N/A	2002-09-01	This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.
NCT00071643 ↗	Preventing Post-Stroke Depression	Completed	Robert G. Robinson	N/A	2002-09-01	This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.
NCT00071643 ↗	Preventing Post-Stroke Depression	Completed	University of Iowa	N/A	2002-09-01	This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.

Clinical Trial Conditions for LEXAPRO

Condition Name

Condition Name for LEXAPRO
Intervention	Trials
Depression	42
Major Depressive Disorder	41
Major Depression	9
Anxiety	9

Condition MeSH

Condition MeSH for LEXAPRO
Intervention	Trials
Depression	102
Depressive Disorder	92
Depressive Disorder, Major	63
Disease	29

Clinical Trial Locations for LEXAPRO

Trials by Country

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Trials by Country for LEXAPRO
Location	Trials
United States	257
China	17
Canada	14
Korea, Republic of	9
Australia	9

Trials by US State

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−

Trials by US State for LEXAPRO
Location	Trials
New York	27
Massachusetts	19
California	19
Pennsylvania	15
Texas	12

Clinical Trial Progress for LEXAPRO

Clinical Trial Phase

Clinical Trial Phase for LEXAPRO
Clinical Trial Phase	Trials
Phase 4	78
Phase 3	11
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for LEXAPRO
Clinical Trial Phase	Trials
Completed	113
Recruiting	16
Unknown status	14

Clinical Trial Sponsors for LEXAPRO

Sponsor Name

Sponsor Name for LEXAPRO
Sponsor	Trials
National Institute of Mental Health (NIMH)	34
Forest Laboratories	25
Massachusetts General Hospital	11

Sponsor Type

Sponsor Type for LEXAPRO
Sponsor	Trials
Other	183
Industry	52
NIH	50

Lexapro (Escitalopram): Clinical Trials, Market Analysis, and Projections

Introduction to Lexapro

Lexapro, also known as escitalopram, is a selective serotonin reuptake inhibitor (SSRI) commonly used to treat major depressive disorder (MDD) and generalized anxiety disorder. Here, we will delve into the current clinical trials, market analysis, and future projections for this medication.

Current Clinical Trials

Pramipexole vs. Escitalopram in Treating MDD and Neurocognitive Disorders

A significant ongoing clinical trial is the phase II study comparing the safety and efficacy of pramipexole extended release (ER) versus escitalopram in treating MDD and comorbid mild neurocognitive disorder (MND) in persons with HIV (PWH)[1].

• Participants and Criteria: The study expects to enroll 186 participants who have documented HIV-1 infection, a diagnosis of MDD, and are on a stable antiretroviral therapy (ART) regimen.
• Assessments: Participants will undergo comprehensive assessments to monitor toxicity, response to therapy, and potential dose changes.
• Sub-Study: An optional sub-study will evaluate the treatment impact on the cerebrospinal fluid (CSF) profile in a subset of 36 participants.
• Completion Date: The study is estimated to complete by December 2026.

Market Analysis

Global Market Trends

The global market for escitalopram is anticipated to experience robust growth over the next few years. Here are some key points from recent market analyses:

• Market Size and Growth: The global escitalopram market is expected to register a significant CAGR in terms of revenue, with the market size projected to increase substantially by 2025[5].
• Regional Markets: In China, the escitalopram market is expected to see a recovery increase from 2021 to 2025, driven by increasing awareness of depression and its treatment, as well as economic development and urbanization[2].

Market Share and Competition

• China Market: Companies such as Sichuan Kelun Pharmaceutical, Jewim Pharmaceutical, Hunan Dongting Pharmaceutical, and Jinhua CONBA hold significant market shares in China. However, the market share of H. Lundbeck A/S's Lexapro has been declining due to the higher cost of the branded drug compared to generics[2].
• Global Market: The global market is dominated by key players, with Lexapro being one of the leading brands. However, generic versions of escitalopram are increasingly popular due to their cost-effectiveness[5].

Efficacy and Safety

Comparative Efficacy

Studies have shown that escitalopram is more effective than its predecessor, citalopram. A meta-analysis revealed that escitalopram had a statistically significant superior efficacy compared to citalopram in treating MDD, with higher response and remission rates[4].

Safety Profile

Clinical trials have highlighted the safety profile of escitalopram. However, like other SSRIs, it can cause adverse events such as insomnia, and in some cases, more severe reactions like convulsions. The FDA recommends caution in patients with severe renal impairment and advises a reduced dose in hepatically impaired patients[3].

Market Projections

Future Growth

The escitalopram market is projected to grow significantly due to several factors:

• Increasing Awareness: Growing awareness of mental health issues and the importance of timely treatment will drive the demand for antidepressants like escitalopram[2].
• Economic and Social Factors: Economic development, urbanization, and changing social attitudes are expected to increase the number of patients seeking treatment for depression[2].
• Generic Competition: While generic versions will continue to compete with branded drugs, the overall market size is expected to expand due to increased demand[5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the escitalopram market. Initially, there was a decline due to disruptions in healthcare services and supply chains. However, as people became more aware of the mental health impacts of the pandemic, the demand for antidepressants has seen a recovery[2].

Key Takeaways

• Clinical Trials: Ongoing trials are comparing escitalopram with other medications to treat MDD and comorbid conditions.
• Market Growth: The global escitalopram market is expected to grow significantly due to increasing awareness of mental health and economic factors.
• Efficacy and Safety: Escitalopram has been shown to be more effective than citalopram and has a generally favorable safety profile, though caution is advised in certain patient groups.
• Market Competition: The market is competitive, with both branded and generic versions available, influencing market share dynamics.

FAQs

What is the current status of the clinical trial comparing pramipexole and escitalopram?

The clinical trial is currently in the phase II stage and is expected to complete by December 2026. It is not yet accepting patients[1].

How does escitalopram compare to citalopram in terms of efficacy?

Escitalopram has been shown to be more effective than citalopram in treating MDD, with higher response and remission rates[4].

What are the major factors driving the growth of the escitalopram market?

The growth is driven by increasing awareness of mental health, economic development, urbanization, and the recovery from the impact of COVID-19[2].

What are the potential side effects of escitalopram?

Common side effects include insomnia, and in some cases, more severe reactions like convulsions. Caution is advised in patients with severe renal impairment and hepatically impaired patients[3].

How is the market share of Lexapro in China evolving?

The market share of Lexapro in China is declining due to the higher cost of the branded drug compared to generics, with local companies gaining market share[2].

Sources

1. Pramipexole Versus Escitalopram to Treat Major Depressive Disorder and Comorbid Mild Neurocognitive Disorder in Persons with HIV - UCSF Clinical Trials.
2. China Escitalopram Market Research Report 2021 - Business Wire.
3. Lexapro (escitalopram oxalate) - FDA.
4. Efficacy of escitalopram compared to citalopram: a meta-analysis - International Journal of Neuropsychopharmacology.
5. Escitalopram Tablets Market to Witness Robust Expansion by 2025 - OpenPR.