Research and Clinical Trials on Paroxetine (Paxil, Seroxat, Deroxat)

Paroxetine (Paxil, Seroxat, Deroxat) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Paroxetine (Paxil, Seroxat, Deroxat).

• Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
  Status: Recruiting, Condition Summary: Major Depressive Disorder
• Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
  Status: Recruiting, Condition Summary: Major Depressive Disorder (MDD)
• Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects
  Status: Not yet recruiting, Condition Summary: Healthy Volunteer
• Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions
  Status: Completed, Condition Summary: Healthy
• Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions
  Status: Completed, Condition Summary: Healthy
• Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects
  Status: Active, not recruiting, Condition Summary: Healthy Volunteer
• Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)
  Status: Terminated, Condition Summary: Posttraumatic Stress Disorder (PTSD)
• PAXIL CR Bioequivalence Study
  Status: Completed, Condition Summary: Two Single Doses of Controlled Release Paroxetine Given 14 Days Apart; Healthy Volunteer
• A Local Register Study For Major Depression Of Paroxetine Controlled Release
  Status: Completed, Condition Summary: Major Depressive Disorder (MDD)
• RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo
  Status: Active, not recruiting, Condition Summary: Phobic Disorders
• Prazosin vs. Paroxetine in Combat Stress Symptoms in OIF/OEF Returnees
  Status: Recruiting, Condition Summary: Sleep Disorders; Stress Disorders, Post-Traumatic
• Combination Of PAXIL Tablet And Benzodiazepines
  Status: Completed, Condition Summary: Depression
• Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects
  Status: Completed, Condition Summary: Pharmacokinetics
• A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
  Status: Completed, Condition Summary: Pharmacokinetics
• Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
  Status: Completed, Condition Summary: Healthy

 

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Current Research Literature on Paroxetine (Paxil, Seroxat, Deroxat)

Here are abstracts for some of the latest research articles to have appeared on Paroxetine (Paxil, Seroxat, Deroxat):

Single prolonged stress: toward an animal model of posttraumatic stress disorder.

Depress Anxiety. 2009 Nov 14;
Yamamoto S, Morinobu S, Takei S, Fuchikami M, Matsuki A, Yamawaki S, Liberzon I
Although selective serotonin reuptake inhibitors (SSRIs) are reported to be effective in decreasing posttraumatic stress disorder (PTSD) symptoms, a subgroup of PTSD patients remain chronically symptomatic and maintain conditioned fear responses to traumatic stimuli. In this context, the establishment of an appropriate animal model of PTSD is necessary to promote better understanding of the mechanisms of the disorder and to facilitate the development of more effective therapeutic alternatives to SSRIs. Although no single widely accepted animal model of PTSD has been established to date, the single prolonged stress (SPS) animal model has been partially validated as a model for PTSD. SPS rats mimic the pathophysiological abnormalities and behavioral characteristics of PTSD, such as enhanced anxiety-like behavior and glucocorticoid negative feedback, and they exhibit the expected therapeutic response to paroxetine on enhanced fear memory. In addition, SPS rats exhibit enhanced freezing in response to contextual fear conditioning, and impaired extinction of fear memory, which is alleviated by D-cycloserine. The enhanced consolidation and impaired extinction of fear memory found in SPS rats suggests that this model has additional value because recent studies of PTSD indicate that memory abnormalities are a central feature. In this study, we summarize the behavioral and pathophysiological PTSD-like symptoms in SPS, focusing on memory abnormalities, and evaluate the validity of SPS as an animal model of PTSD. Depression and Anxiety 0:1-8, 2009. (c) 2009 Wiley-Liss, Inc.

New nonextractive and highly sensitive high-performance liquid chromatographic method for determination of paroxetine in plasma after offline precolumn derivatization with 7-chloro-4-nitrobenzo-2-oxa-1,3-diazole.

J AOAC Int. 2009 Sep-Oct; 92(5): 1349-55
Darwish IA, Al-Majed AA, Mahmoud AM, Khalil NY
New nonextractive and simple offline precolumn derivatization procedures have been proposed, for the first time, for the trace determination of paroxetine (PXT) in human plasma by HPLC with fluorescence detection. Trimetazidine (TMZ) was used as an internal standard. Plasma samples were treated with acetonitrile for protein precipitation and then derivatized with 7-chloro-4-nitrobenzo-2-oxa-1,3-diazole in borate buffer of pH 8 at 70 degrees C for 30 min. Separations of the derivatized PXT and TMZ were performed on a Nucleosil CN column using a mobile phase consisting of acetonitrile-10 mM sodium acetate buffer (pH 3.5)-methanol (47 + 47 + 6, v/v) at a flow rate of 1.0 mL/min. The derivatized samples were excited at 470 nm and monitored at an emission wavelength of 530 nm. Under the optimum chromatographic conditions, a linear relationship with good correlation coefficient (r = 0.9998, n = 7) was found between the peak area ratio and PXT concentrations in the range of 5-600 ng/mL. The LOD and LOQ were 1.37 and 4.14 ng/mL, respectively. The intraday and interassay precisions were satisfactory; the RSD did not exceed 4.2%. The accuracy of the method was proved by recovery of PXT from spiked human plasma at levels of 97.28-104.38 +/- 0.41-3.62%. The proposed method had high throughput, as the analysis involved a simple sample pretreatment procedure and short run time (< 10 min). The results demonstrated that the method would have a great value when it is applied in the therapeutic monitoring of PXT.

Effects of Selective Serotonin Reuptake Inhibitors on Timolol Metabolism in Human Liver Microsomes and Cryo-Preserved Hepatocytes.

Basic Clin Pharmacol Toxicol. 2009 Nov 11;
Volotinen M, Korjamo T, Tolonen A, Turpeinen M, Pelkonen O, Hakkola J, Mäenpää J
Timolol has been widely used in the treatment of glaucoma. Topically applied, timolol may cause adverse cardiovascular effects due to systemic absorption through the nasolacrimal duct. Timolol is mainly metabolized by cytochrome P450 2D6 (CYP2D6) in the liver. The aim of the present study was to characterize further the metabolism of timolol in vitro. Especially the effect of several drugs such as selective serotonin reuptake inhibitors on the metabolism of timolol was evaluated. In human liver microsomes, four timolol metabolites were identified, in cryo-preserved hepatocytes nine. In both in vitro experiments, the hydroxy metabolite M1 was the main metabolite. The in vivo half-life predicted for timolol was 3.7 hr. in cryo-preserved hepatocytes, corresponding to the half-life of timolol in humans in vivo. Fluoxetine, paroxetine, sertraline, citalopram and fluvoxamine inhibited the formation of M1 in microsomes with IC(50) values of 1.4, 2.0, 3.5, 21 and 20 muM, respectively. In human cryo-preserved hepatocytes, the IC(50) values for fluoxetine, paroxetine and fluvoxamine were 0.7, 0.5 and 5.9 muM, respectively. In conclusion, compounds known to be potent CYP2D6 inhibitors inhibited timolol metabolism in in vitro experiments. The present results strongly suggest that fluoxetine and paroxetine may significantly affect the metabolism of timolol also in vivo and may thus potentiate the adverse cardiovascular effects of topically administered timolol.

Dialysis-associated increase in the saliva level of paroxetine.

J Clin Psychopharmacol. 2009 Dec; 29(6): 619-20
Tsuruta T, Tanaka K, Ishikawa K, Yang C, Ueki H, Matsunaga M, Tatebayashi H, Yamada S

Comparative efficacy and acceptability of pharmacotherapeutic agents for anxiety disorders in children and adolescents: a mixed treatment comparison meta-analysis.

Curr Med Res Opin. 2009 Nov 11;
Uthman OA, Abdulmalik J
Abstract Objective: to compare efficacy and acceptability of different pharmacotherapeutic agents for treating anxiety disorders in children and adolescents Methods: A recently conducted Cochrane Review on pharmacotherapy for anxiety disorders in children and adolescents was updated. A mixed treatment comparison meta-analysis using Bayesian Markov Chain Monte Carlo simulation was used to perform the indirect comparison. We calculated relative risk ratios (RR) with 95% credible interval (CrI) using placebo as the common comparator. Results: Data were combined from 16 clinical trials that randomized children to six different treatment strategies, including placebo. Fluoxetine, fluvoxamine, paroxetine, sertraline, and venlafaxine were more efficacious than placebo. Venlafaxine was significantly less efficacious than fluvoxamine (RR = 0.60; 95% CrI 0.35-0.95) and paroxetine (RR = 0.65; 95% CrI 0.44-0.93). Fluoxetine, fluvoxamine, paroxetine, and sertraline had higher acceptability profile than placebo. Venlafaxine was less tolerated than fluvoxamine (RR = 0.16; 95% CrI 0.01-0.64), paroxetine (RR = 0.21; 95% CrI 0.05-0.59), and sertraline (RR = 0.31; 95% CrI 0.08-0.83). Fluvoxamine had a higher rate of clinical response and acceptability compared to other treatments in the network, with probability of 47.5% and 50.6% of being the most efficacious and well-tolerated treatment, respectively. Conclusion: Clinically important differences exist between commonly prescribed pharmacotherapeutic agents for treating anxiety among children in terms of both efficacy and acceptability in favor of fluvoxamine. Fluvoxamine might be the best choice when starting treatment for anxiety disorders among children and adolescents because it has the most favorable balance between benefits and acceptability.