Vilazodone for the Treatment of Depression: An Update

Wang, Sheng-Min,Han, Changsu,Lee, Soo-Jung,Patkar, Ashwin A.,Masand, Prakash S,Pae, Chi-Un Chonnam National University Medical School 2016 CMJ Vol.52 No.2

<P>Vilazodone is a novel antidepressant having a selective serotonin (5-HT) reuptake inhibitor and 5-HT1A receptor partial agonist profile, so it has been regarded as a serotonin partial agonist-reuptake inhibitor (SPARI). We aimed to provide Vilazodone's clinical implications mainly by reviewing published clinical trials. Vilazodone has been speculated to have three potential benefits including faster onset of action, greater efficacy, and better tolerability owning to its SPARI properties. However, no studies conducted so far have directly proven the above speculations. Five initial phase II trials failed to distinguish vilazodone from placebo in the treatment of MDD, but 4 randomized clinical trials (RCT), 3 post-hoc or pooled analysis, 1 long-term open label study, and a meta-analysis showed vilazodone's superior efficacy over placebo. The studies also showed vilazodone is generally safe and tolerable. However, diarrhea, nausea, headache, dizziness, dry mouth, and insomnia warrant close attention in clinical practice because they have been constantly noted throughout the clinical studies. 2 RCTs recently documented the efficacy and safety of vilazodone in patients with generalized anxiety disorder, which could be a start of broadening vilazodone's usage or FDA approval in diverse anxiety disorders.</P>

Vilazodone for the Treatment of Depression: An Update

Sheng Min Wang,한창수,이수정,Ashwin A. Patkar,Prakash S. Masand,배치운 전남대학교 의과학연구소 2016 전남의대학술지 Vol.52 No.2

Vilazodone is a novel antidepressant having a selective serotonin (5-HT) reuptake inhibitorand 5-HT1A receptor partial agonist profile, so it has been regarded as a serotoninpartial agonist-reuptake inhibitor (SPARI). We aimed to provide Vilazodone’s clinicalimplications mainly by reviewing published clinical trials. Vilazodone has been speculatedto have three potential benefits including faster onset of action, greater efficacy,and better tolerability owning to its SPARI properties. However, no studies conductedso far have directly proven the above speculations. Five initial phase II trials failed todistinguish vilazodone from placebo in the treatment of MDD, but 4 randomized clinicaltrials (RCT), 3 post-hoc or pooled analysis, 1 long-term open label study, and ameta-analysis showed vilazodone’s superior efficacy over placebo. The studies alsoshowed vilazodone is generally safe and tolerable. However, diarrhea, nausea, headache,dizziness, dry mouth, and insomnia warrant close attention in clinical practicebecause they have been constantly noted throughout the clinical studies. 2 RCTs recentlydocumented the efficacy and safety of vilazodone in patients with generalizedanxiety disorder, which could be a start of broadening vilazodone’s usage or FDA approvalin diverse anxiety disorders.

Addressing the side effects of contemporary antidepressant drugs: a comprehensive review

왕승민,한창수,박원명,이수정,Ashwin A. Patkar,Prakash S. Masand,배치운 전남대학교 의과학연구소 2018 전남의대학술지 Vol.54 No.2

Randomized trials have shown that selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have better safety profiles than classical tricyclic antidepressants (TCAs). However, an increasing number of studies, including meta-analyses, naturalistic studies, and longer-term studies suggested that SSRIs and SNRIs are no less safe than TCAs. We focused on comparing the common side effects of TCAs with those of newer generation antidepressants including SSRIs, SNRIs, mirtazapine, and bupropion. The main purpose was to investigate safety profile differences among drug classes rather than the individual antidepressants, so studies containing comparison data on drug groups were prioritized. In terms of safety after overdose, the common belief on newer generation antidepressants having fewer side effects than TCAs appears to be true. TCAs were also associated with higher drop-out rates, lower tolerability, and higher cardiac side-effects. However, evidence regarding side effects including dry mouth, gastrointestinal side effects, hepatotoxicity, seizure, and weight has been inconsistent, some studies demonstrated the superiority of SSRIs and SNRIs over TCAs, while others found the opposite. Some other side effects such as sexual dysfunction, bleeding, and hyponatremia were more prominent with either SSRIs or SNRIs.

Does Pregabalin Have Neuropsychotropic Effects?: A Short Perspective

David M. Marks,Ashwin A. Patkar,Prakash S. Masand,배치운 대한신경정신의학회 2009 PSYCHIATRY INVESTIGATION Vol.6 No.2

Pregabalin is a newly developed synthetic gamma-aminobutyric acid (GABA) that is approved for the treatment of fibromyalgia and several neuropathy. It has been proven to show analgesic, anxiolytic, anticonvulsant and sleep enhancement effects, which could be applicable in the treatment of a variety of psychiatric disorders. There have been consistent reports that unexplained somatic symptoms (i.e., pain) may be a part of psychiatric disorders such as major depressive disorder (MDD) and anxiety disorders. Previous researches have also suggested the possible therapeutic potential of anticonvulsants as augmentation therapy or monotherapy in the treatment of mood disorders and anxiety disorders. Hence this short perspective tries to prompt and facilitate a shifting of researchers’ attention to potential neuropsychotropic drug role of pregabalin to treat a wide range of neuropsychiatric disorders.

Erratum: Correction of Acknowledgements Second Generation Antipsychotics in the Treatment of Major Depressive Disorder: An Update

왕승민,한창수,이수정,전태연,Ashwin A. Patkar,Prakash S. Masand,배치운 전남대학교 의과학연구소 2019 전남의대학술지 Vol.55 No.1

Vilazodone for the Treatment of Major Depressive Disorder: Focusing on Its Clinical Studies and Mechanism of Action

ShengMin Wang,Changsu Han,SooJung Lee,Ashwin A Patkar,Prakash S Masand,Chi-Un Pae 대한신경정신의학회 2015 PSYCHIATRY INVESTIGATION Vol.12 No.2

We tried to review and update clinical and preclinical studies evaluating vilazodone’s role as an antidepressant for patients with major depressive disorder (MDD). In terms of its mechanism of actions, we sought to elaborate them mainly through preclinical animal studies. A data search was conducted in November 1, 2013, using the key terms “vilazodone” or “Viibryd,” in PubMed and Medline databases. All published and unpublished studies are included and citations from publications were also reviewed for additional references. Five unpublished, phase-II and two pivotal published phase-III clinical trials with nearly identical design (8-week, double-blind, randomized, and placebo-controlled) investigated efficacy of vilazodone, were found for the treatment of patients with MDD. Two post-hoc studies and one long-term open study were also included. Data were thoroughly reviewed to incorporate the pharmacology, action mechanism, efficacy and safety for the vilazodone in the treatment of major depressive disorder. Vilazodone is an antidepressant with novel mechanism of action because its chemical structure is unrelated to conventional antidepressant, and it has a selective serotonin (5-HT) reuptake inhibitor and 5-HT1A receptor partial agonist profile. Vilazodone is an effective and safe treatment option with its novel action mechanisms for patients with depression. Its putative benefits compared with other antidepressants must be thoroughly studied in adequately-powered and well-designed future clinical trials.

Consideration of Long-Acting Injectable Antipsychotics for Polypharmacy Regimen in the Treatment of Schizophrenia: Put It on the Table or Not?

배치운,Changsu Han,Won-Myong Bahk,Soo-Jung Lee,Ashwin A. Patkar,Prakash S. Masand 대한정신약물학회 2021 CLINICAL PSYCHOPHARMACOLOGY AND NEUROSCIENCE Vol.19 No.3

Antipsychotic monotherapy (APM) is considered best-acceptable treatment option regardless of antipsychotic class and formulation types for treating schizophrenia. However, antipsychotic polypharmacy (APP) has been also widely utilized in routine clinical practice. Despite APP has some clinical benefits it has also numerous pitfalls in relation with increased total number and doses of APs leading to adverse events as well as decrease of treatment adherence and persistence resulting in poor clinical outcomes. Recent introduction of long-acting injectable antipsychotics (LAIs) to the market has offered a chance for better medication adherence/persistence and also provided a simplification of treatment regime leading to more stabilized treatment for schizophrenia patients. When we cannot stay away from APP in the treatment of schizophrenia, clinicians need to find more proper APP regimens and thereby utilization of APP in efficient way should be a practical strategy to benefit schizophrenia patient in a real world treatment setting. With this regard, LAIs can be one of available APP regimen for treatment of schizophrenia in routine practice since their clinical utility and pharmacokinetic stability over oral APs have been well-elaborated today. However, when we have to commence LAIs as a part of APP with oral APs or other LAIs, every effort should be made before doing so whether or not validated and available treatment options or other clinical factors were not done or evaluated yet. Any treatment guidelines do not support APP regardless of the formulation of APP regimen or address two or more LAIs for treatment of schizophrenia till today.

Atypical antipsychotics as a possible treatment option for irritable bowel syndrome

Pae, Chi-Un,Lee, Soo-Jung,Han, Changsu,Patkar, Ashwin A,Masand, Prakash S Informa UK, Ltd. 2013 Expert opinion on investigational drugs Vol.22 No.5

<P><B><I>Introduction:</I></B> Irritable bowel syndrome (IBS) is a prevalent functional gastrointestinal disorder (FGID) that is characterised by chronic abdominal pain, discomfort, bloating, and alteration of bowel habits. Although the pathophysiology of IBS is not fully understood, it is believed that psychiatric comorbidities are highly common in such patients. A variety of psychotropic medications are widely used in the treatment of IBS, particularly older antidepressants such as tricyclic antidepressants (TCAs).</P><P><B><I>Areas covered:</I></B> With the advent of newer antidepressant classes with better safety and tolerability compared with TCAs, such as serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), clinicians now have more advanced treatment options for treating IBS. Additionally, some atypical antipsychotics (AAs) have recently received approval for treatment of major depressive disorder (MDD). Some AAs may have potentials based on their pharmacodynamic profile and proven benefit for mood symptoms, pain, anxiety and sleep disturbances. This article describes the potential rationale, clinical data and practical aspects involved in the use of AAs for patients with IBS.</P><P><B><I>Expert opinion:</I></B> Atypical antipsychotics (AAs) may have a role in the treatment of irritable bowel syndrome (IBS) based on the currently available findings, although there is no clear evidence, and a number of clinical issues to be addressed in the use of AAs for the treatment of IBS.</P>

Desvenlafaxine succinate: a newer antidepressant for the treatment of depression and somatic symptoms.

Seo, Ho-Jun,Sohi, Manmohandeep Singh,Patkar, Ashwin A,Masand, Prakash S,Pae, Chi-Un McGraw-Hill] 2010 Postgraduate medicine Vol.122 No.1

<P>Desvenlafaxine succinate (DVS) is one of several serotonin-norepinephrine reuptake inhibitors (SNRIs). Others are venlafaxine hydrochloride, milnacipran, and duloxetine. Desvenlafaxine has been approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) based on a number of randomized, placebo-controlled clinical trials. Clinical studies have investigated the efficacy of DVS in doses ranging from 50 to 400 mg/day for the treatment of MDD in adult outpatients. The effects of DVS 50 mg/day have been clearly distinguished from placebo in the reduction of MDD symptoms in such clinical trials. No additional therapeutic benefits were found at doses > 50 mg/day. The recommended dose of DVS ranges from 50 to 100 mg. Desvenlafaxine is currently the third SNRI approved by the FDA for this indication. Preliminary evidence also suggests the clinical usefulness of DVS in the treatment of vasomotor symptoms of menopause, anxiety symptoms, and painful physical symptoms. The modified pharmacokinetic and pharmacodynamic profiles of DVS differentiate this drug from the original product, venlafaxine. Significant points of difference, compared with venlafaxine, are once-daily dosing and the achievement of steady-state plasma concentrations within 4 to 5 days. To summarize, current evidence indicates that DVS has proven efficacy, acceptable safety and tolerability profiles, convenient dosing, and minimal impact on the cytochrome P450 enzyme system. A reduced risk for pharmacokinetic drug interactions is a potential advantage over other selective serotonin noradrenaline reuptake inhibitors. Desvenlafaxine succinate has demonstrated its efficacy for treating MDD but its variable efficacy, as shown in individual studies, limited long-term data, and its different risk-to-benefit ratio compared with earlier antidepressants, means that further investigation of this drug is necessary.</P>

Aripiprazole augmentation for treatment of patients with inadequate antidepressants response

Pae, Chi-Un,Patkar, Ashwin A.,Jun, Tae-Youn,Lee, Chul,Masand, Prakash S.,Paik, In-Ho Wiley Subscription Services, Inc., A Wiley Company 2007 Depression and Anxiety Vol.24 No.7

<P>This study evaluated whether or not augmentation with aripiprzazole is beneficial and tolerable to patients with an inadequate response to antidepressants (ADs). Thirteen patients with nonpsychotic major depression, who had failed to respond to an adequate trial of at least one AD, were prescribed aripiprazole (dose, 5–30 mg) for 8 weeks. The dose of their preexisting ADs was not changed. The treatment response was defined as the mean changes in the scores of the Hamilton Depression Rating Scale (HAM-D) from the baseline to the end of treatment. Eleven (84.6%) patients returned for at least one follow-up visit, and 7 (53.8%) patients completed the study. The HAM-D and Clinical Global Impression—Severity (CGI-S) scores decreased significantly from the baseline to the end of treatment by 53.8% and 56.0%, respectively (Z = −2.937, P =.003; Z = −2.961, P =.003). Seven (63.6%) patients showed a ≥ 50% reduction in the HAM-D score at the end of treatment. Three (27.3%) patients met the remission criteria at the end of treatment. There were no serious side effects. Despite the high dropout rate in this open study, aripiprazole appears to be reasonably effective and tolerated as an augmentation strategy in conjunction with conventional ADs treatment in patients with an inadequate AD response. These results highlight the potential benefits of aripiprazole for these patients. However, adequately powered, randomized, controlled trials are needed to confirm these results. Depression and Anxiety 24:522–526, 2007. © 2006 Wiley-Liss, Inc.</P>