CLINICAL TRIALS PROFILE FOR REMERON

All Clinical Trials for Remeron

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00249444 ↗	Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2006-05-01	Many substance dependent individuals also suffer from depression. Past research suggests that antidepressant medication is helpful in treating such individuals. This study will determine the effectiveness of mirtazapine, an antidepressant medication, in treating cocaine dependent individuals who also suffer from depression. This study includes free treatment for cocaine dependence that includes medication and a behavioral intervention.
NCT00249444 ↗	Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression	Completed	New York State Psychiatric Institute	Phase 2	2006-05-01	Many substance dependent individuals also suffer from depression. Past research suggests that antidepressant medication is helpful in treating such individuals. This study will determine the effectiveness of mirtazapine, an antidepressant medication, in treating cocaine dependent individuals who also suffer from depression. This study includes free treatment for cocaine dependence that includes medication and a behavioral intervention.
NCT00288782 ↗	PET Neuroimaging of [11C]Mirtazapine	Completed	Fund for Advancement of Medical Science	Phase 4	2006-02-01	Recent studies show that 25 - 30% of depressed patients never fully recover, resulting in a treatment-resistant condition. Thus, depression is a major cause of human suffering. We are interested in finding new ways of identifying and alleviating treatment-resistant depression, and we believe that recent advances in brain imaging can contribute to achieving that goal. In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented for examining the neurochemistry of brain receptors involved in antidepressant actions. Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic receptors that have often been implicated in "stress reactions" as well as depressive disorders. We believe that our compound can identify specific molecular brain dysfunctions that are causally related to treatment-resistant depression. The purpose of this study is to determine whether there is a reliable relationship between the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and region-of-interest data analysis, using healthy volunteers who will receive a daily dose of mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe that this project could provide a procedure for assessing brain function in treatment-resistant depression, with the aim of improving the guidelines for successful, evidence-based treatment of depression.
NCT00288782 ↗	PET Neuroimaging of [11C]Mirtazapine	Completed	Max Woerzner's Research Award	Phase 4	2006-02-01	Recent studies show that 25 - 30% of depressed patients never fully recover, resulting in a treatment-resistant condition. Thus, depression is a major cause of human suffering. We are interested in finding new ways of identifying and alleviating treatment-resistant depression, and we believe that recent advances in brain imaging can contribute to achieving that goal. In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented for examining the neurochemistry of brain receptors involved in antidepressant actions. Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic receptors that have often been implicated in "stress reactions" as well as depressive disorders. We believe that our compound can identify specific molecular brain dysfunctions that are causally related to treatment-resistant depression. The purpose of this study is to determine whether there is a reliable relationship between the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and region-of-interest data analysis, using healthy volunteers who will receive a daily dose of mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe that this project could provide a procedure for assessing brain function in treatment-resistant depression, with the aim of improving the guidelines for successful, evidence-based treatment of depression.
NCT00288782 ↗	PET Neuroimaging of [11C]Mirtazapine	Completed	The Danish Medical Research Council	Phase 4	2006-02-01	Recent studies show that 25 - 30% of depressed patients never fully recover, resulting in a treatment-resistant condition. Thus, depression is a major cause of human suffering. We are interested in finding new ways of identifying and alleviating treatment-resistant depression, and we believe that recent advances in brain imaging can contribute to achieving that goal. In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented for examining the neurochemistry of brain receptors involved in antidepressant actions. Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic receptors that have often been implicated in "stress reactions" as well as depressive disorders. We believe that our compound can identify specific molecular brain dysfunctions that are causally related to treatment-resistant depression. The purpose of this study is to determine whether there is a reliable relationship between the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and region-of-interest data analysis, using healthy volunteers who will receive a daily dose of mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe that this project could provide a procedure for assessing brain function in treatment-resistant depression, with the aim of improving the guidelines for successful, evidence-based treatment of depression.

Clinical Trial Conditions for Remeron

Condition Name

Condition Name for Remeron
Intervention	Trials
Major Depressive Disorder	8
Depression	4
Healthy	4
Cocaine Dependence	3

Condition MeSH

Condition MeSH for Remeron
Intervention	Trials
Depression	14
Depressive Disorder	13
Depressive Disorder, Major	11
Disease	7

Clinical Trial Locations for Remeron

Trials by Country

Trials by Country for Remeron
Location	Trials
United States	24
China	5
Egypt	2
Brazil	2
Canada	2

Trials by US State

Trials by US State for Remeron
Location	Trials
North Dakota	4
Pennsylvania	3
New York	3
Virginia	2
California	2

Clinical Trial Progress for Remeron

Clinical Trial Phase

Clinical Trial Phase for Remeron
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	4
Phase 2	12

Clinical Trial Status

Clinical Trial Status for Remeron
Clinical Trial Phase	Trials
Completed	27
Unknown status	3
Withdrawn	3

Clinical Trial Sponsors for Remeron

Sponsor Name

Sponsor Name for Remeron
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	5
Capital Medical University	3
University of Pittsburgh	2

Sponsor Type

Sponsor Type for Remeron
Sponsor	Trials
Other	47
NIH	11
Industry	5

REMERON (Mirtazapine): Clinical Trials Update, Market Analysis, and Projections

Introduction to REMERON (Mirtazapine)

REMERON, known generically as mirtazapine, is an antidepressant medication primarily used to treat major depressive disorder (MDD). It belongs to the class of tetracyclic antidepressants and works by modulating the levels of certain neurotransmitters in the brain.

Clinical Trials Update

Efficacy in Major Depressive Disorder

Mirtazapine has been extensively studied in clinical trials for its efficacy in treating MDD. In several placebo-controlled trials, mirtazapine demonstrated superiority over placebo in reducing symptoms of depression, as measured by the Hamilton Depression Rating Scale (HDRS), Montgomery and Asberg Depression Rating Scale (MADRS), and other clinical assessments[3].

Long-Term Efficacy

Long-term studies have shown that mirtazapine is effective in maintaining a response in patients with MDD. A study where patients were randomized to continuation of mirtazapine or placebo after an initial 8 to 12 weeks of acute treatment showed significantly lower relapse rates in those receiving continued mirtazapine treatment[3].

Use in Anxious Depression

Recent findings suggest that mirtazapine may have benefits in treating anxious depression, although it failed to augment SSRIs and SNRIs in some large randomized controlled trials. There was a small signal suggesting benefit on secondary measures of anxiety, indicating potential utility in this area[1].

Methamphetamine Abuse

Mirtazapine has shown promise in helping individuals stay off methamphetamine. A study found that mirtazapine modulates the monoamine depletion associated with methamphetamine withdrawal, leading to improved outcomes in terms of reduced methamphetamine use and associated behaviors[1].

Breathlessness in Respiratory Diseases

A recent phase 3 trial, the BETTER B trial, investigated the efficacy of mirtazapine in reducing breathlessness in patients with respiratory diseases. However, the trial found mirtazapine to be ineffective in this context, urging caution against off-label use for this indication[4].

Market Analysis

Current Market Size and Growth

The mirtazapine drug market has been valued and projected to grow significantly. As of 2017, the market was valued at a certain amount and is projected to reach a higher value by 2025, with a notable compound annual growth rate (CAGR)[2].

Global Market Trends

The global antidepressant drugs market, which includes mirtazapine, is expected to grow substantially. By 2033, the market is anticipated to reach a revenue of USD 26.9 billion, growing at a CAGR of 3.3% from 2025. This growth is driven by increasing demand for effective antidepressant treatments[5].

Regional Market Insights

The consumption of mirtazapine varies by region, with key markets including North America, Europe, Asia-Pacific, Central & South America, Middle East, and Africa. The report highlights the production capacity, value, and market share of major manufacturers in these regions[2].

Projections and Future Outlook

Market Growth Projections

The antidepressant drugs market, including mirtazapine, is projected to continue growing due to the increasing prevalence of mental health disorders and the need for effective treatments. The global market is expected to reach significant values by 2033, driven by a steady CAGR[5].

Emerging Trends and Opportunities

The market for mirtazapine is likely to benefit from emerging trends such as personalized medicine and the integration of digital health technologies. These trends could enhance patient outcomes and improve the overall efficiency of treatment protocols.

Side Effects and Precautions

Common Side Effects

Mirtazapine is associated with several common side effects, including somnolence (reported in 54% of patients), increased appetite, and weight gain. Other side effects include dizziness and sleep disturbances[3].

Renal and Hepatic Impairment

Caution is advised when administering mirtazapine to patients with compromised renal or hepatic function. Studies have shown reduced clearance of mirtazapine in patients with moderate to severe renal impairment and hepatic insufficiency[3].

Conclusion

Mirtazapine, marketed as REMERON, remains a significant player in the treatment of major depressive disorder. While it has shown efficacy in various clinical trials, its use in other conditions such as breathlessness in respiratory diseases has been less successful. The market for mirtazapine is projected to grow, driven by the increasing demand for effective antidepressant treatments.

Key Takeaways

• Efficacy in MDD: Mirtazapine is effective in treating major depressive disorder, as demonstrated in multiple clinical trials.
• Long-Term Use: It is effective in maintaining a response in patients over long-term use.
• Anxious Depression: Shows potential benefits in treating anxious depression.
• Methamphetamine Abuse: Helps individuals stay off methamphetamine by modulating monoamine depletion.
• Market Growth: The mirtazapine market is projected to grow significantly by 2025 and beyond.
• Side Effects: Common side effects include somnolence, increased appetite, and weight gain.

FAQs

What is the primary use of REMERON (mirtazapine)?

REMERON (mirtazapine) is primarily used to treat major depressive disorder (MDD).

What are the common side effects of mirtazapine?

Common side effects include somnolence, increased appetite, weight gain, and dizziness.

Is mirtazapine effective in treating anxious depression?

Mirtazapine shows potential benefits in treating anxious depression, although it failed to augment SSRIs and SNRIs in some trials.

Can mirtazapine be used to treat breathlessness in respiratory diseases?

No, recent trials have found mirtazapine to be ineffective in reducing breathlessness in patients with respiratory diseases.

What is the projected market growth for mirtazapine?

The mirtazapine market is projected to grow significantly, with the global antidepressant drugs market expected to reach USD 26.9 billion by 2033.

Sources

1. The Carlat Report: Nine New Findings with Mirtazapine.
2. OpenPR: Mirtazapine Drug Market Is Likely to Witness Tremendous Growth by 2025.
3. FDA: Remeron (mirtazapine) tablets.
4. HCPLive: Mirtazapine Fails to Ease Breathlessness in New Study Despite Previous Hopes.
5. GlobeNewswire: Antidepressant Drugs Market is expected to reach a revenue of USD 26.9 Bn by 2033 at 3.3% CAGR.