Effects of tandospirone augmentation in major depressive disorder patients with high anxiety: A multicenter, randomized, parallel-controlled, open-label study

Lin, Jinyu; Su, Yun-Ai; Wang, Chunxia; Yang, Fang; Xu, Yi; Yuan, Yonggui; Yao, Yuan; Wang, Xiaoping; Yu, Xin; Si, Tianmei

doi:10.1016/j.jpsychires.2018.01.020

Cited by 26 publications

(14 citation statements)

References 40 publications

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“…The present study found that tandospirone treatment was well tolerated. The adverse drug reactions were similar to those of other antidepressants that acted on the 5-HT system to treat anxiety disorders and depression, primarily dizziness and gastrointestinal reaction [24]. Among the adverse drug reactions, only dizziness was signi cantly increased in the high-dose group, one patient withdrew from the study for this reason.…”

Section: Discussionmentioning

confidence: 56%

Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial

Zhang

Lin

et al. 2021

Preprint

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Background This study aimed to determine the safety and efficacy of different doses of tandospirone to treat generalized anxiety disorder (GAD). Methods This parallel randomized controlled trial involved patients with GAD from eight centers in China between 01/2012 and 09/2018. Patients were randomly assigned to 60 mg/day and 30 mg/day groups. The primary endpoint was the overall response rate at the end of week 6. The secondary endpoints included significant response rate, change in Hamilton Anxiety Scale (HAMA) total score, HAMA subscale score, Hamilton Depression Scale-17 (HAMD-17), and adverse drug reactions. Results No significant difference was found in the overall response rate (65.7% vs 58.4%, P > 0.05) between 60 mg/day and 30 mg/day groups. The significant response rate (34.3% vs 22.6%, P = 0.032) was better in the 60 mg/day group. The reduction in HAMA total score, somatic anxiety factor, cardiovascular symptom factor, gastrointestinal symptom factor, and HAMD-17 score were better in the 60 mg/day group (all P < 0.05). The incidence of dizziness and gastrointestinal reactions of the 60 mg/day group was higher than that of the 30 mg/day group. However, there was no significant difference in the proportion of withdrawal due to adverse events. Conclusions For GAD treatment, the overall response rate of high-dose tandospirone was similar to that of low-dose tandospirone. The safety in the two groups was tolerable. Patients with good compliance might benefit from a high-dose regimen. Trial registration: The trial registration no. was NCT01614041(07/06/2012).

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Section: Discussionmentioning

confidence: 56%

Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial

Zhang

Lin

et al. 2021

Preprint

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“…Gepirone ER is currently in Phase 2 trials for GAD, MDD, and hypoactive sexual desire disorder (103). Tandospirone, yet another azapirone studied for depression and anxiety, showed promise in reducing anxiety in patients with anxious depression (104,105). There was one completed trial of tandospirone in GAD but no published results yet (NCT01614041).…”

Section: Novel Treatments For Anxiety Disordersmentioning

confidence: 99%

Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options

Garakani¹,

Murrough²,

Freire³

et al. 2021

FOC

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Anxiety disorders are the most prevalent psychiatric disorders and a leading cause of disability. While there continues to be expansive research in posttraumatic stress disorder (PTSD), depression and schizophrenia, there is a relative dearth of novel medications under investigation for anxiety disorders. This review's first aim is to summarize current pharmacological treatments (both approved and off-label) for panic disorder (PD), generalized anxiety disorder (GAD), social anxiety disorder (SAD), and specific phobias (SP), including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), azapirones (e.g., buspirone), mixed antidepressants (e.g., mirtazapine), antipsychotics, antihistamines (e.g., hydroxyzine), alpha-and beta-adrenergic medications (e.g., propranolol, clonidine), and GABAergic medications (benzodiazepines, pregabalin, and gabapentin). Posttraumatic stress disorder and obsessive-compulsive disorder are excluded from this review. Second, we will review novel pharmacotherapeutic agents under investigation for the treatment of anxiety disorders in adults. The pathways and neurotransmitters reviewed include serotonergic agents, glutamate modulators, GABAergic medications, neuropeptides, neurosteroids, alpha-and beta-adrenergic agents, cannabinoids, and natural remedies. The outcome of the review reveals a lack of randomized double-blind placebocontrolled trials for anxiety disorders and few studies comparing novel treatments to existing anxiolytic agents. Although there are some recent randomized controlled trials for novel agents including neuropeptides, glutamatergic agents (such as ketamine and d-cycloserine), and cannabinoids (including cannabidiol) primarily in GAD or SAD, these trials have largely been negative, with only some promise for kava and PH94B (an inhaled neurosteroid). Overall, the progression of current and future psychopharmacology research in anxiety disorders suggests that there needs to be further expansion in research of these novel pathways and largerscale studies of promising agents with positive results from smaller trials.

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“…Tandospirone also seems to be effective against depression and other anxiety disorders because serotonin 1A receptor agonists produce downregulation of postsynaptic serotonin 2 receptors (Feighner & Boyer, ). Tandospirone may improve outcomes in major depressive disorder patients with high anxiety (Lin et al, ).…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of tandospirone and its active metabolite, 1‐[2‐pyrimidyl]‐piperazine in rat plasma by LC–MS/MS and its application to a pharmacokinetic study

et al. 2019

Biomedical Chromatography

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A rapid, sensitive and selective liquid chromatography–tandem mass spectrometry method for the detection of tandospirone (TDS) and its active metabolite 1‐[2‐pyrimidyl]‐piperazine (1‐PP) in Sprague–Dawley rat plasma is described. It was employed in a pharmacokinetic study. These analytes and the internal standards were extracted from plasma using protein precipitation with acetonitrile, then separated on a CAPCELL PAK ADME C18 column using a mobile phase of acetonitrile and 5 mm ammonium formate acidified with formic acid (0.1%, v/v) at a total flow rate of 0.4 mL/min. The detection was performed with a tandem mass spectrometer equipped with an electrospray ionization source. The method was validated to quantify the concentration ranges of 1.000–500.0 ng/mL for TDS and 10.00–500.0 ng/mL for 1‐PP. Total time for each chromatograph was 3.0 min. The intra‐day precision was between 1.42 and 6.69% and the accuracy ranged from 95.74 to 110.18% for all analytes. Inter‐day precision and accuracy ranged from 2.47 to 6.02% and from 98.37 to 105.62%, respectively. The lower limits of quantification were 1.000 ng/mL for TDS and 10.00 ng/mL for 1‐PP. This method provided a fast, sensitive and selective analytical tool for quantification of tandospirone and its metabolite 1‐PP in plasma necessary for the pharmacokinetic investigation.

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Effects of tandospirone augmentation in major depressive disorder patients with high anxiety: A multicenter, randomized, parallel-controlled, open-label study

Cited by 26 publications

References 40 publications

Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial

Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial

Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options

Simultaneous determination of tandospirone and its active metabolite, 1‐[2‐pyrimidyl]‐piperazine in rat plasma by LC–MS/MS and its application to a pharmacokinetic study

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