Efficacy and Safety of Mirtazapine in Major Depressive Disorder Patients After SSRI Treatment Failure
University of Washington Seattle, Seattle, Washington, United States The Journal of Clinical Psychiatry
(Impact Factor: 5.5).
07/2001; 62(6):413-20. DOI: 10.4088/JCP.v62n0603
To evaluate the efficacy and safety of mirtazapine in depressed outpatients who have shown nonresponse or intolerance to selective serotonin reuptake inhibitor (SSRI) therapy.
In this open-label, 8-week study, the efficacy and safety of mirtazapine among 103 outpatients with DSM-IV major depressive disorder who had failed previous therapy with an SSRI (fluoxetine, paroxetine, or sertraline) were evaluated. The primary efficacy measure was the 17-item Hamilton Rating Scale for Depression (HAM-D-17), and safety assessments included reported adverse events, routine laboratory assessments, physical examinations, and assessments of vital signs. A 4-day washout period followed by mirtazapine treatment was compared with an immediate switch from the SSRI to mirtazapine.
Based on mean HAM-D-17 scores at endpoint and response rates of 48% based on the criterion of > or = 50% reduction in HAM-D-17 score, mirtazapine was found to be an effective treatment for a substantial proportion of patients for whom an SSRI was ineffective and/or poorly tolerated. Mirtazapine was well tolerated, with sedation and appetite increase/weight gain the most commonly reported adverse events. In addition, no difference in efficacy, safety, or tolerability was observed for patients undergoing an immediate switch from an SSRI (after having been tapered to the minimal effective dose) to mirtazapine, compared with those undergoing the imposition of a 4-day drug-free washout.
These results suggest that an immediate switch to mirtazapine may be a valid therapeutic option among patients who cannot tolerate or do not respond to SSRIs.
Available from: Angel Luis Montejo
- "A variety of different ways of switching between antidepressants may be employed, some of which have been studied in clinical trials (e.g. Fava et al., 2001; Kreider et al., 1995). Previous switching studies have not however studied in detail what happens to PPS associated with depression following antidepressant switch. "
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ABSTRACT: Painful physical symptoms (PPS) are common in patients with depression. Our objective was to evaluate the presence of PPS in a sample of SSRI non- or partial-responders with MDD and examine the effect of a switch to duloxetine on those PPS. Outpatients who met criteria for MDD despite having taken an SSRI antidepressant for at least 6 weeks, and who had a Hamilton depression rating scale total score of at least 15 and a clinical global impression of severity score of at least 3, were randomized to switch to duloxetine by either a direct switch or a start-taper switch method. PPS were assessed at baseline and at the study endpoint using various measures including six visual analog scales (VAS) for pain (overall pain, headache, back pain, shoulder pain, interference with daily activities, and time in pain while awake), the pain subscale of the symptom questionnaire-somatic subscale, and the bodily pain subscale of the short form-36 item health survey. Clinically significant levels of pain (mean baseline VAS scores >30 mm) were seen across all VAS pain measures prior to switching. Switch to duloxetine was associated with significant improvements on all pain measures regardless of switch method, and there was evidence for an earlier reduction in pain in the start-taper switch group. In summary, MDD patients who were non- or partial-responders to SSRI treatment were found to have clinically significant pain which improved significantly following switch to duloxetine regardless of the switch method utilized.
Available from: Domenico De Berardis
- "Mirtazapine also selectively inhibits specific postsynaptic 5-HT2 and 5-HT3 receptors and histamine-H1 receptors, and this contributes to its favourable tolerability profile. The antidepressant effect and tolerability of mirtazapine have been well documented (Fava et al., 2001), but the amount of research on the efficacy and tolerability of this drug in the treatment of GAD is hitherto very limited. In a randomized double-blind trial in nondepressed patients with a primary anxiety disorder, mirtazapine showed a continuously increasing anxiolytic effect over 28 days that was statistically superior to the effect of placebo (Sitsen and Moors, 1994). "
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ABSTRACT: We investigated the efficacy of mirtazapine in the treatment of generalized anxiety disorder (GAD). Forty-four adult outpatients with GAD were treated openly with a fixed dose of mirtazapine (30 mg) for 12 weeks. The primary outcome measure was the change from baseline in total score on the Hamilton Rating Scale for Anxiety (HAM-A). The Clinical Global Impression of Improvement (CGI-I) was rated at the endpoint. Patients with a reduction of 50% or more on the HAM-A total score and a CGI-I score of 1 or 2 at endpoint were considered responders to treatment; remission was defined as a HAM-A score <or=7. At 12 weeks, response was achieved by 79.5% of the patients (n=35) and remission by 36.4% of patients (n=16). This study supports the notion that mirtazapine is an efficacious and well tolerated treatment for GAD. Limitations of the present study must be considered and further placebo-controlled trials are needed.
Available from: Tae-Youn Jun
- "Of note is the fact that none of our patients withdrew in response to these side-effects. The degree of weight increase associated with mirtazapine treatment was comparable to that reported in other studies (Fava et al., 2001; Thase et al., 2001). "
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ABSTRACT: This study was aimed at testing the efficacy and tolerability of mirtazapine in the treatment of Korean patients with chronic post-traumatic stress disorder (PTSD). Mirtazapine was administered for 8 weeks using a flexible-dose regime in 15 Korean patients with PTSD based on the DSM-IV criteria. We evaluated the patients at baseline and at weeks 4 and 8 after treatment with the interviewer-administered structured interview for PTSD (SIP), short PTSD rating interview (SPRINT), impact of event scale-revised (IES-R) and the Montgomery Asberg depression rating scale (MADRS). Scores on the SIP, SPRINT, IES-R and MADRS had significantly reduced after 8 weeks treatment. In this pilot study, mirtazapine was found to be effective and well tolerated in the treatment of patients with PTSD. This calls for further evaluation of the effect of this drug on subjects with PTSD with randomized placebo-controlled studies.
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