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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR MIRTAZAPINE


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All Clinical Trials for Mirtazapine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00021528 ↗ Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Completed National Institute of Mental Health (NIMH) Phase 4 2001-07-01 STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated
NCT00080158 ↗ Treatment of Adolescent Suicide Attempters (TASA) Completed National Institute of Mental Health (NIMH) Phase 2/Phase 3 2004-03-01 The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide.
NCT00080158 ↗ Treatment of Adolescent Suicide Attempters (TASA) Completed New York State Psychiatric Institute Phase 2/Phase 3 2004-03-01 The purpose of this study is to compare the effects of three types of treatments for depressed teenagers who have attempted suicide.
NCT00108498 ↗ New Pharmacological Treatment for Obstructive Sleep Apnea Completed US Department of Veterans Affairs Phase 1 2003-10-01 This study will determine if mirtazapine, a unique antidepressant that does not disturb sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover, double blind, and placebo controlled. On two consecutive nights of one week, the patients receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative medication is administered. The patients have known mild to moderate sleep apnea. The endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of arterial oxygen desaturation.
NCT00108498 ↗ New Pharmacological Treatment for Obstructive Sleep Apnea Completed VA Office of Research and Development Phase 1 2003-10-01 This study will determine if mirtazapine, a unique antidepressant that does not disturb sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover, double blind, and placebo controlled. On two consecutive nights of one week, the patients receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative medication is administered. The patients have known mild to moderate sleep apnea. The endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of arterial oxygen desaturation.
NCT00150839 ↗ Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy Completed University of Erlangen-Nürnberg Phase 4 2006-03-01 The proposed study is a randomized, placebo-controlled, double-blind trial to evaluate the safety and efficacy of antidepressant combination for the treatment of depression. Depressive disorder is one of the most common human diseases with a high burden for every patient, her/his family, health care system and society as a whole. Actual treatment concepts of depressive disorders include pharmacologic, biologic (e.g. electroconvulsive therapy, light therapy) and psychologic therapy. Even though effective therapeutic options are at hand, therapy needs time. It is often not possible to reach full remission of the disease and 10-25% of patients suffering from depression are regarded as "treatment-resistant". In treatment resistant depression, the use of a combination of antidepressive drugs is considered safe and effective. However, at present no data exist concerning the use of drug combination as primary therapeutic option. The aim of the study is to examine the hypothesis, that significantly more patients achieve full remission of depressive symptoms when treated with the combination of two antidepressants and as a secondary hypothesis, that patients receiving a drug combination will achieve remission faster than patients treated with monotherapy. To test these hypotheses, a two group parallel design is used comparing the efficacy and safety of mirtazapine in combination with venlafaxine or placebo.
NCT00150839 ↗ Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy Completed University of Erlangen-Nürnberg Medical School Phase 4 2006-03-01 The proposed study is a randomized, placebo-controlled, double-blind trial to evaluate the safety and efficacy of antidepressant combination for the treatment of depression. Depressive disorder is one of the most common human diseases with a high burden for every patient, her/his family, health care system and society as a whole. Actual treatment concepts of depressive disorders include pharmacologic, biologic (e.g. electroconvulsive therapy, light therapy) and psychologic therapy. Even though effective therapeutic options are at hand, therapy needs time. It is often not possible to reach full remission of the disease and 10-25% of patients suffering from depression are regarded as "treatment-resistant". In treatment resistant depression, the use of a combination of antidepressive drugs is considered safe and effective. However, at present no data exist concerning the use of drug combination as primary therapeutic option. The aim of the study is to examine the hypothesis, that significantly more patients achieve full remission of depressive symptoms when treated with the combination of two antidepressants and as a secondary hypothesis, that patients receiving a drug combination will achieve remission faster than patients treated with monotherapy. To test these hypotheses, a two group parallel design is used comparing the efficacy and safety of mirtazapine in combination with venlafaxine or placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mirtazapine

Condition Name

Condition Name for Mirtazapine
Intervention Trials
Depression 14
Major Depressive Disorder 12
Healthy 6
Anorexia 6
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Condition MeSH

Condition MeSH for Mirtazapine
Intervention Trials
Depression 34
Depressive Disorder 27
Depressive Disorder, Major 20
Disease 15
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Clinical Trial Locations for Mirtazapine

Trials by Country

Trials by Country for Mirtazapine
Location Trials
United States 111
China 12
Germany 6
Egypt 5
Pakistan 4
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Trials by US State

Trials by US State for Mirtazapine
Location Trials
Texas 9
Pennsylvania 8
North Carolina 8
New York 8
California 8
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Clinical Trial Progress for Mirtazapine

Clinical Trial Phase

Clinical Trial Phase for Mirtazapine
Clinical Trial Phase Trials
Phase 4 26
Phase 3 17
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Mirtazapine
Clinical Trial Phase Trials
Completed 57
Recruiting 11
Unknown status 11
[disabled in preview] 20
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Clinical Trial Sponsors for Mirtazapine

Sponsor Name

Sponsor Name for Mirtazapine
Sponsor Trials
National Institute of Mental Health (NIMH) 5
Ain Shams University 5
National Institute on Drug Abuse (NIDA) 5
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Sponsor Type

Sponsor Type for Mirtazapine
Sponsor Trials
Other 137
Industry 19
NIH 15
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Mirtazapine: Clinical Trials, Market Analysis, and Projections

Clinical Trials Update

Study of Mirtazapine for Agitated Behaviours in Dementia (SYMBAD)

A significant clinical trial, the SYMBAD study, investigated the efficacy of mirtazapine in treating agitated behaviors in patients with dementia. This three-arm trial included mirtazapine, carbamazepine, and a placebo group, with participants randomized on a 1:1:1 basis. The trial aimed to assess the clinical effectiveness of mirtazapine in reducing agitation, measured by the Cohen-Mansfield Agitation Inventory (CMAI) score at 12 weeks.

  • Dosage and Procedure: Participants started with one 15 mg capsule of mirtazapine, increasing to two capsules at 2 weeks and three capsules at 4 weeks, reaching a target dose of 45 mg per day. The trial also monitored secondary outcomes such as health-related quality of life, neuropsychiatric symptoms, and carer mental health[1].

  • Outcomes: The study found that mirtazapine was not clinically effective compared to the placebo in reducing agitation in dementia patients. The carbamazepine arm was discontinued due to efficacy and safety concerns[1].

Mirtazapine as an Appetite Stimulant

Another clinical trial published in JAMA Oncology explored the use of mirtazapine as an appetite stimulant in patients with non-small cell lung cancer (NSCLC) and anorexia. This randomized, double-blind, placebo-controlled trial involved patients receiving either mirtazapine (15 mg escalating to 30 mg) or a placebo.

  • Results: The trial showed that while there was no significant difference in appetite scores between the mirtazapine and placebo groups, the mirtazapine group had a significant increase in energy intake, particularly in fat intake, which is crucial for energy requirements. This suggests that mirtazapine may help improve health-related quality of life in these patients[4].

Market Analysis

Global Market Size and Growth

The global mirtazapine market is projected to experience significant growth over the coming years. According to Cognitive Market Research, the market size is expected to be USD XX million in 2024 and will expand at a compound annual growth rate (CAGR) of 5.50% from 2024 to 2031[2][5].

Regional Market Share

  • North America: This region holds the major market share, accounting for more than 40% of the global market. The presence of major key players, continuous technological development, and a well-developed healthcare sector contribute to this dominance[2][5].

  • Asia-Pacific: This region is expected to grow at a CAGR of 7.5% from 2024 to 2031, driven by increasing research and development activities, rising investment in the healthcare sector, and growing demand for treatment[2].

  • Europe: Europe is also anticipated to see significant growth, with countries like the UK, Germany, and France contributing to the regional market expansion[2].

Market Drivers

The growth of the mirtazapine market is driven by several factors:

  • Increasing Geriatric Population: The rising number of elderly individuals, who are more prone to conditions such as depression and anxiety, is a key driver[2][3].

  • Prevalence of Depression and Anxiety: The increasing prevalence of depression, anxiety disorders, and other mental health conditions is boosting the demand for mirtazapine[3].

  • Government Initiatives and Awareness: Growing government initiatives and rising awareness about mental health treatments are also contributing to market growth[3].

Market Segmentation

The mirtazapine market is segmented based on type, formulation dosage, application, demographic, end-users, and distribution channels.

  • Formulation Dosage: Tablets, particularly those in strengths of 15 mg and 30 mg, are expected to dominate the market due to their simplicity and precise dosage[2].

  • Applications: Mirtazapine is used for treating depression, obsessive-compulsive disorder, anxiety disorders, and other conditions[3].

Market Projections

Forecast Period

The forecast period for the global mirtazapine market spans from 2024 to 2031. Here are some key projections:

  • Global Growth: The market is expected to grow at a CAGR of 5.50% during this period, driven by the factors mentioned above[2][5].

  • Regional Growth: Asia-Pacific is expected to be the fastest-growing region, with a CAGR of 7.5%, followed by Europe and North America[2].

  • Market Size: By 2031, the global mirtazapine market is projected to reach a significant size, driven by the increasing demand and favorable market conditions[2].

Challenges and Opportunities

While the market is poised for growth, there are several challenges and opportunities to consider:

  • Side Effects and Interactions: Mirtazapine can cause side effects such as serotonin syndrome, irregular heartbeat, and allergic reactions, which can hamper market growth. However, managing these side effects through proper dosing and monitoring can present opportunities for improved patient outcomes[3].

  • Emerging Revenue Pockets: The increasing use of antidepressants for various conditions and the growing awareness about mental health treatments present opportunities for market expansion[3].

Key Takeaways

  • Clinical Efficacy: Mirtazapine has shown mixed results in clinical trials, with no significant benefit in treating agitated behaviors in dementia but potential benefits as an appetite stimulant in cancer patients.

  • Market Growth: The global mirtazapine market is expected to grow significantly, driven by an increasing geriatric population, rising prevalence of mental health conditions, and growing awareness.

  • Regional Dynamics: North America currently dominates the market, but the Asia-Pacific region is expected to be the fastest-growing segment.

  • Challenges and Opportunities: Managing side effects and leveraging emerging revenue pockets are crucial for market growth.

FAQs

What is the primary use of mirtazapine?

Mirtazapine is primarily used as an antidepressant for treating depression, anxiety disorders, obsessive-compulsive disorder, and insomnia. It works by balancing the chemical messengers or neurotransmitters in the brain to regulate mood[3].

What were the findings of the SYMBAD study on mirtazapine?

The SYMBAD study found that mirtazapine was not clinically effective compared to a placebo in reducing agitation in dementia patients. The carbamazepine arm was discontinued due to efficacy and safety concerns[1].

How does mirtazapine affect appetite in cancer patients?

In a clinical trial, mirtazapine was found to significantly increase energy intake, particularly fat intake, in patients with non-small cell lung cancer and anorexia, which can help improve their health-related quality of life[4].

What are the key drivers of the global mirtazapine market?

The key drivers include an increasing geriatric population, rising prevalence of depression and anxiety, growing government initiatives, and rising awareness about mental health treatments[2][3].

Which region is expected to be the fastest-growing in the mirtazapine market?

The Asia-Pacific region is expected to be the fastest-growing segment, with a CAGR of 7.5% from 2024 to 2031[2].

Sources

  1. The Lancet: "Study of mirtazapine for agitated behaviours in dementia (SYMBAD)"[1].
  2. Cognitive Market Research: "Global Mirtazapine Market Report 2024"[2].
  3. Data Bridge Market Research: "Global Mirtazapine Drug Market – Global Industry Trends and Forecast to 2028"[3].
  4. JAMA Oncology: "Mirtazapine as Appetite Stimulant in Patients With Non–Small Cell Lung Cancer and Anorexia: A Randomized Clinical Trial"[4].

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