CLINICAL TRIALS PROFILE FOR OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

All Clinical Trials for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00188942 ↗	A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder	Completed	Eli Lilly and Company	Phase 4	2005-02-01	This study employs functional magnetic resonance imaging to compare brain activation patterns during a depressive episode in patients diagnosed with bipolar disorder, major depressive disorder, and a group of healthy control subjects. Depressed patients will be treated with a combination of fluoxetine and olanzapine and undergo MRI scans before, during, and after pharmacotherapy.
NCT00188942 ↗	A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder	Completed	University Health Network, Toronto	Phase 4	2005-02-01	This study employs functional magnetic resonance imaging to compare brain activation patterns during a depressive episode in patients diagnosed with bipolar disorder, major depressive disorder, and a group of healthy control subjects. Depressed patients will be treated with a combination of fluoxetine and olanzapine and undergo MRI scans before, during, and after pharmacotherapy.
NCT00191399 ↗	Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response	Completed	Eli Lilly and Company	Phase 4	2004-05-01	The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).
NCT00485771 ↗	Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression	Completed	Eli Lilly and Company	Phase 4	2003-11-01	The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.
NCT00035321 ↗	The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression	Completed	Eli Lilly and Company	Phase 3	2002-04-01	The purposes of this study are to determine: - Whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression. - The safety of olanzapine plus fluoxetine in combination, plus and any side effects that might be associated with the combination. - The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine alone.
NCT00000373 ↗	Treatment of Obsessive-Compulsive Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	1992-09-01	The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
NCT00000373 ↗	Treatment of Obsessive-Compulsive Disorder	Completed	University of Florida	Phase 4	1992-09-01	The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.

Clinical Trial Conditions for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Condition Name

Condition Name for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Intervention	Trials
Bipolar Depression	4
Major Depressive Disorder	3
Treatment Resistant Depression	2
Bipolar Disorder	2

Condition MeSH

Condition MeSH for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Intervention	Trials
Depression	13
Depressive Disorder	12
Bipolar Disorder	7
Disease	4

Clinical Trial Locations for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Trials by Country

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Trials by Country for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Location	Trials
United States	46
Canada	5
China	3
Puerto Rico	2
India	2

Trials by US State

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−

Trials by US State for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Location	Trials
Pennsylvania	3
Massachusetts	3
California	3
New York	2
Indiana	2

Clinical Trial Progress for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	3
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	11
Recruiting	3
Terminated	1

Clinical Trial Sponsors for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Sponsor	Trials
Eli Lilly and Company	7
National Alliance on Mental Illness Westside Los Angeles	1
University Health Network, Toronto	1

Sponsor Type

Sponsor Type for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Sponsor	Trials
Other	18
Industry	9
NIH	1

Olanzapine and Fluoxetine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Olanzapine and fluoxetine hydrochloride, commonly known as Symbyax, is a combination medication used for the treatment of bipolar depression and treatment-resistant depression. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Integrated Analysis of Olanzapine/Fluoxetine Combination

Clinical trials have shown that the combination of olanzapine and fluoxetine (OFC) is significantly more effective than either medication alone in treating depressive symptoms. A comprehensive analysis involving 1146 patients with major depressive disorder demonstrated that OFC-treated patients experienced greater improvements in depressive symptoms compared to those treated with olanzapine or fluoxetine monotherapy. This was evident through the Montgomery-Asberg Depression Rating Scale, where OFC patients showed a mean change of -13.0, significantly better than fluoxetine (-8.6) and olanzapine (-8.2) groups[2].

Pediatric Studies

In pediatric patients aged 10-17 years with bipolar I disorder, OFC was found to be statistically superior to placebo in treating major depressive episodes. Studies conducted under the Pediatric Research Equity Act (PREA) showed significant improvements in the Children’s Depression Rating Scale-revised (CDRS-R) total score, highlighting the efficacy of OFC in this age group[4].

Safety and Adverse Events

Common Adverse Events

The combination therapy is associated with several adverse events, including weight gain, increased appetite, dry mouth, somnolence, fatigue, headache, and peripheral edema. Notably, OFC patients experienced significant increases in cholesterol levels and body weight compared to those on fluoxetine monotherapy[2].

Risk Benefit Assessment

The use of OFC carries risks such as weight gain, metabolic syndrome, QTc prolongation, hyperprolactinemia, and increased suicidal thoughts. However, these risks are balanced by the significant clinical benefits in treating major depressive episodes associated with bipolar I disorder[4].

Market Analysis

Global Market Size and Growth

The global olanzapine market, which includes the combination therapy with fluoxetine, was valued at $1.8 billion in 2021 and is projected to reach $2.2 billion by 2031, growing at a CAGR of 2.3% from 2022 to 2031. This growth is driven by the increasing prevalence of mental disorders, particularly schizophrenia and bipolar disorder, and government initiatives to improve healthcare infrastructure[1].

Regional Market Performance

North America holds a significant market share due to the high demand for olanzapine drugs, driven by the prevalence of schizophrenia in this region. However, the Asia-Pacific region is expected to witness the highest growth rate during the forecast period, attributed to increasing government initiatives and investments in healthcare[1].

Key Market Players

Major players in the olanzapine market include Alkermes, Apotex Inc., Aurobindo Pharma, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Novartis AG, Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals Industries Ltd., Torrent Power Ltd, and Viatris Inc.[1].

Market Segmentation

By Application

The market is segmented into schizophrenia, bipolar disorder, and other applications. The schizophrenia segment dominated the global market in 2021, driven by the rising incidence of mental illnesses. For instance, according to the National Institute of Mental Health (NIH), 52.9 million adults in the U.S. lived with mental illness in 2020[1].

By Distribution Channel

The distribution channels for olanzapine include retail pharmacies, hospitals, and online pharmacies. The rise in the number of drug stores and retail pharmacies, especially in the Asia-Pacific region, has contributed to market growth[1].

Challenges and Opportunities

High Cost and Side Effects

Despite the market growth, the high cost of olanzapine and its associated side effects, such as weight gain and metabolic changes, may hamper market expansion. However, these challenges are offset by the high growth potential in developing economies and the ongoing R&D activities and product approvals[1].

Government Initiatives

Government initiatives to provide better facilities for mental disorder patients and promote a healthy lifestyle are significant drivers of the market. For example, data from the World Health Organization (WHO) indicates that 1 in every 8 people worldwide lives with a mental disorder, highlighting the need for effective treatments like OFC[1].

Mechanism of Action

Synergistic Effects

The combination of olanzapine and fluoxetine works by activating three monoaminergic neural systems: serotonin, norepinephrine, and dopamine. Animal studies have shown that this combination produces synergistic increases in norepinephrine and dopamine release in the prefrontal cortex, enhancing the antidepressant effect[4].

Pediatric Use

Safety Review

The FDA has conducted pediatric-focused safety reviews for Symbyax, which have not identified any new safety signals. The medication is approved for use in pediatric patients aged 10 years and older for the treatment of bipolar depression and treatment-resistant depression[3].

Key Takeaways

• Efficacy: OFC has shown significant efficacy in treating depressive symptoms in both adult and pediatric populations.
• Safety: While associated with several adverse events, the benefits of OFC in treating major depressive episodes outweigh the risks.
• Market Growth: The global olanzapine market is projected to grow at a CAGR of 2.3% from 2022 to 2031.
• Regional Performance: North America and Asia-Pacific are key regions driving market growth.
• Government Initiatives: Increased government support for mental health infrastructure is a significant market driver.

FAQs

What is the projected market size of the olanzapine market by 2031?

The global olanzapine market is projected to reach $2.2 billion by 2031[1].

What are the common adverse events associated with the olanzapine and fluoxetine combination?

Common adverse events include weight gain, increased appetite, dry mouth, somnolence, fatigue, headache, and peripheral edema[2].

In which age group is the olanzapine and fluoxetine combination approved for pediatric use?

The combination is approved for use in pediatric patients aged 10 years and older[3].

Which regions are expected to drive the growth of the olanzapine market?

North America and the Asia-Pacific region are expected to drive market growth, with the latter witnessing the highest growth rate during the forecast period[1].

What are the key drivers of the olanzapine market growth?

Key drivers include the rising incidence of mental disorders, government initiatives to improve healthcare infrastructure, and increasing investments in R&D activities[1].

Sources

1. Allied Market Research: Olanzapine Market Size, Share | Report Forecast By 2031
2. PubMed: An integrated analysis of olanzapine/fluoxetine combination in treatment-resistant depression
3. FDA: Symbyax (olanzapine and fluoxetine hydrochloride) Pediatric Advisory Committee Meeting
4. FDA: Olanzapine and fluoxetine HCL Clinical PREA