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.

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
Canada	2
Egypt	2
Brazil	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
Actavis Inc.	2

Sponsor Type

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