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 | >Sponsor | >Phase | >Start Date | >Summary |
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