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The Journal of Clinical Psychiatry Nov 2001The objective of this double-blind, placebo-controlled study was to investigate the efficacy and safety of paroxetine in outpatients with posttraumatic stress disorder... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
BACKGROUND
The objective of this double-blind, placebo-controlled study was to investigate the efficacy and safety of paroxetine in outpatients with posttraumatic stress disorder (PTSD).
METHOD
Male and female outpatients 18 years and older who met DSM-IV criteria for PTSD and had baseline scores of 50 or greater on the Clinician Administered PTSD Scale (CAPS-2) were randomly assigned to treatment with paroxetine (20-50 mg/day) or placebo for 12 weeks. The primary efficacy variables were the change from baseline to the 12-week endpoint in the CAPS-2 total score and the proportion of responders on the Clinical Global Impressions-Global Improvement scale (CGI-1). Additional key outcome measures were the change from baseline in the reexperiencing, avoidance/ numbing, and hyperarousal scores of the CAPS-2 and in the total scores of the Treatment Outcome PTSD Scale and the patient-rated Davidson Trauma Scale and Sheehan Disability Scale (SDS). Depressive symptoms were assessed with the Montgomery-Asberg Depression Rating Scale. The proportion of patients achieving response and remission was also determined.
RESULTS
307 patients constituted the intent-to-treat population. At week 12, compared with the placebo group (N = 156), the paroxetine group (N = 151) showed significantly greater reduction of PTSD symptoms on both of the primary and all of the secondary outcome measures. Significantly greater improvement on the CAPS-2 total score was observed for paroxetine compared with placebo from week 4 (p < .05), and significantly greater proportions of paroxetine-treated patients achieved response (p < .001) and remission (p = .008) by week 12. The improvement in PTSD symptoms was similar in male and female patients. Functional improvement at the study endpoint was significantly greater (p < .05) in the paroxetine group in all 3 domains of the SDS (work, social life, family life). Treatment with paroxetine was well tolerated, with the frequency and type of adverse events recorded for the paroxetine group corresponding to the known safety profile of this medication.
CONCLUSION
Paroxetine in doses of 20 to 50 mg once daily is effective as a treatment for chronic PTSD. Improvement is obtained for all 3 symptom clusters (reexperiencing, avoidance/numbing, hyperarousal) and is associated with significant reduction in disability after 12 weeks of treatment.
Topics: Adolescent; Adult; Aged; Chronic Disease; Disability Evaluation; Double-Blind Method; Drug Administration Schedule; Drug Tolerance; Female; Humans; Male; Middle Aged; Paroxetine; Selective Serotonin Reuptake Inhibitors; Stress Disorders, Post-Traumatic; Time Factors; Treatment Outcome
PubMed: 11775045
DOI: 10.4088/jcp.v62n1105 -
Psychopharmacology Mar 2012Clinical data show that paroxetine causes sexual dysfunction in a substantial proportion of women taking this compound.
RATIONALE
Clinical data show that paroxetine causes sexual dysfunction in a substantial proportion of women taking this compound.
OBJECTIVES
This work was conducted to determine whether chronic paroxetine reduces sexual incentive motivation in female rats and whether this compound can modify any aspect of paced mating. The role of the 5-HT(1B) and 5-HT(2C) receptors in any potential effects was also evaluated.
METHODS
Ovariectomized female rats were implanted with osmotic minipumps releasing 10 mg/kg per day of paroxetine or vehicle for 28 days. Tests for sexual incentive motivation and paced mating were performed just before implantation and at regular intervals thereafter. The females were primed with estradiol benzoate (25 μg/rat) and progesterone (1 mg/rat) before each of these tests. On days 25-27 of treatment, the females were injected with the 5-HT(1B) antagonist GR125,743 (5 mg/kg), the 5-HT(2C) antagonist SB206,553 (5 mg/kg) and vehicle in counterbalanced order. Preinjection time was 30 min.
RESULTS
Paroxetine reduced sexual incentive motivation on day 20 of treatment without affecting any aspect of paced mating. None of the antagonists modified the inhibitory effect of paroxetine on sexual incentive motivation. In the group chronically treated with vehicle, SB206,553 reduced proceptive behaviors in the paced mating test. No other effect was obtained.
CONCLUSION
The effects of paroxetine seen in female rats are similar to those observed in women, suggesting that disturbances of sexual incentive motivation in rats are predictive of sexual dysfunction in women. The 5-HT(1B) and 5-HT(2C) receptors do not seem to be of any importance for paroxetine's inhibitory effect.
Topics: Animals; Benzamides; Drug Interactions; Female; Indoles; Infusion Pumps, Implantable; Male; Motivation; Paroxetine; Pyridines; Rats; Rats, Wistar; Serotonin 5-HT1 Receptor Antagonists; Serotonin 5-HT2 Receptor Antagonists; Selective Serotonin Reuptake Inhibitors; Sexual Behavior, Animal
PubMed: 21909633
DOI: 10.1007/s00213-011-2475-1 -
Journal of the American Academy of... Nov 2004To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder. (Clinical Trial)
Clinical Trial Randomized Controlled Trial
OBJECTIVE
To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder.
METHOD
Children (7-11 years of age) and adolescents (12-17 years of age) meeting DSM-IV criteria for obsessive-compulsive disorder were randomized to paroxetine (10-50 mg/day) or placebo for 10 weeks. The primary efficacy measure was change from baseline in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score at week 10 last observation carried forward end point. Safety was assessed primarily through adverse event monitoring.
RESULTS
A total of 207 patients were randomized to treatment. Of these, 203 were included in the intention-to-treat population. Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 (SE=0.82) and -5.34 points (SE=0.77), respectively. The adjusted mean difference, -3.45 in favor of paroxetine, was statistically significant (95% confidence interval=-5.60 to -1.29, p=.002). Adverse events were generally mild to moderate in intensity. A total of 10.2% (10/98) of patients in the paroxetine group and 2.9% (3 of 105) in the placebo group discontinued treatment because of adverse events.
CONCLUSIONS
Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents.
Topics: Administration, Oral; Adolescent; Child; Double-Blind Method; Female; Humans; Male; Obsessive-Compulsive Disorder; Paroxetine; Placebos; Selective Serotonin Reuptake Inhibitors; Treatment Outcome
PubMed: 15502598
DOI: 10.1097/01.chi.0000138356.29099.f1 -
Pharmacotherapy 1994Major depression afflicts a significant percentage of the population, and optimum therapy is often limited by the poor tolerability and lethality in overdose of the... (Review)
Review
Major depression afflicts a significant percentage of the population, and optimum therapy is often limited by the poor tolerability and lethality in overdose of the tricyclic antidepressants. The selective serotonin reuptake inhibitors (SSRIs) fluoxetine, sertraline, and, more recently, paroxetine are viewed as welcome additions to existing therapy. The SSRIs are as effective as the tricyclic antidepressants, but are not associated with their adverse effect profile. Paroxetine in dosages of 20-50 mg/day is as effective as the older classic antidepressants, including amitriptyline, imipramine, and doxepin. It is effective in the elderly and in patients with recurrent, resistant, or severe depression.
Topics: Aged; Antidepressive Agents, Tricyclic; Anxiety Disorders; Clinical Trials as Topic; Depression; Drug Interactions; Humans; Paroxetine; Recurrence
PubMed: 8197030
DOI: No ID Found -
Psychopharmacology Jul 2015After exposure to a severe traumatic event, avoidance, fear sensitization, and increased anxiety are among features that can persist over time in people developing...
RATIONALE
After exposure to a severe traumatic event, avoidance, fear sensitization, and increased anxiety are among features that can persist over time in people developing posttraumatic stress disorder (PTSD). Basic research on treatment interfering with these symptoms can provide insights to improve PTSD treatment.
OBJECTIVES
The purposes of the present study were to induce these behavioral changes in mice and examine whether paroxetine would interfere with their expression.
METHODS
Mice were submitted to avoidance training with a low (0.4 mA) or high (1.5 mA) foot-shock intensity, as mild and severe stressors, respectively, and posttraining avoidance was evaluated 1 and 12 days later. Fear sensitization, measured as increased freezing to a neutral tone, and enhanced contextual fear, measured as increased freezing to a conditioned context (wherein all mice received a 0.4-mA foot-shock), were assessed during this time window. An elevated plus maze test was also used to assess mouse anxiety-like behavior.
RESULTS
Persistent avoidance, persistent fear sensitization, and long-term enhancement of contextual fear and increased anxiety-like behavior were established only in mice that received the 1.5-mA foot-shock during avoidance training. Paroxetine (at 8 mg/kg/day), injected from day 5 to day 11 after avoidance training, suppressed all of these behavioral changes.
CONCLUSIONS
These data provide additional evidence for the role of paroxetine against expression of PTSD-like behaviors in mice.
Topics: Animals; Anxiety; Avoidance Learning; Electroshock; Fear; Male; Mice; Paroxetine; Stress Disorders, Post-Traumatic; Treatment Outcome
PubMed: 25585683
DOI: 10.1007/s00213-014-3861-2 -
International Clinical... Jun 1992A total of 101 patients entered a double-blind, parallel-group study in general practice, comparing the efficacy and tolerability of paroxetine and amitriptyline in... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
A total of 101 patients entered a double-blind, parallel-group study in general practice, comparing the efficacy and tolerability of paroxetine and amitriptyline in elderly depressed patients. All patients received placebo for 1 week followed by active therapy for a total of 6 weeks. Medication was randomly allocated, two-thirds of the patients took paroxetine (20 mg daily) and one-third received amitriptyline (50 mg daily); this dose was increased to 30 mg and 100 mg, respectively, after 1 week. Of the patients who entered the placebo run-in, 90 took active treatment and were evaluable on an intention-to-treat basis (56 paroxetine, 32 amitriptyline). The mean age of the patients was 72 years. Significant reductions in Hamilton Depression Rating Scale (HAMD) from baseline to the end of treatment were seen for both groups (p < 0.01), with no difference between treatments. The HAMD score was reduced by half, or more, for 76% of patients taking paroxetine and 86% taking amitriptyline. Significant improvement was observed in the investigators' Clinical Global Impression (CGI) score for 57% of patients taking paroxetine and 52% on amitriptyline. Improvements after treatment were also observed in the Leeds Sleep Evaluation Questionnaire (LSEQ) scores. Significantly fewer patients taking paroxetine reported adverse events (34% vs 63% taking amitriptyline, p = 0.02). Those taking paroxetine experienced significantly fewer anticholinergic side effects (7% vs 25% taking amitriptyline, p = 0.04). Overall, this study confirmed the effectiveness of paroxetine as an antidepressant drug.(ABSTRACT TRUNCATED AT 250 WORDS)
Topics: Aged; Amitriptyline; Depressive Disorder; Double-Blind Method; Female; Humans; Male; Paroxetine; Psychiatric Status Rating Scales
PubMed: 1431010
DOI: 10.1097/00004850-199206004-00009 -
Casopis Lekaru Ceskych 2019We currently have a wide range of antidepressants available. However, the mechanisms of action are different, giving a theoretical justification for their combination in...
We currently have a wide range of antidepressants available. However, the mechanisms of action are different, giving a theoretical justification for their combination in the failure of monotherapy. However, the combination of drugs entails, in addition to benefits, an increase in the risk of, for example, drug interactions. Many drug interactions in psychiatry are due to the pharmacokinetic interactions between drugs, where their plasma concentrations are altered by inhibiting or inducing cytochrome P450 isoenzymes, especially CYP2D6 and CYP3A4 and P-glycoprotein. When treating depression, we should consider the risks and benefits of combination therapy in individual patients and take measures to minimize the side effects of medicines. The case report describes a case of a patient who reported significant depression after adding paroxetine and mirtazapine to psychiatric medication. As a theoretical cause, it discusses the possible clinically demonstrated interaction between paroxetine and mirtazapine, which has been clinically manifested by fatigue and pronounced daytime sleepiness.
Topics: Antidepressive Agents; Cytochrome P-450 Enzyme System; Depression; Drug Interactions; Humans; Mirtazapine; Paroxetine
PubMed: 31995999
DOI: No ID Found -
Psychiatry and Clinical Neurosciences Aug 2004The efficacy of paroxetine in the treatment of obsessive-compulsive disorder in Western populations is well established. The present study compares the efficacy and... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
The efficacy of paroxetine in the treatment of obsessive-compulsive disorder in Western populations is well established. The present study compares the efficacy and safety of paroxetine with placebo in the treatment of obsessive-compulsive disorder in Japanese patients. Patients aged 16 years or older who met Diagnostic and Statistical Manual of Mental Disorders (4th edn; DSM-IV) criteria for obsessive-compulsive disorder and had a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of >/=16 were randomized to receive 12 weeks' therapy in a double-blind manner. Paroxetine 20-50 mg/day or placebo was administered following a 1 week, placebo run-in phase. One hundred and ninety-one patients were randomized to either paroxetine or placebo, 188 patients were assessed as the full analysis set (FAS) and 144 patients completed the 12 week study. After adjustment for the Y-BOCS total score at baseline, reductions in obsessive-compulsive total score at week 6 and at the end of therapy were significantly greater in the paroxetine group than the placebo group. Most of the adverse events that occurred during the study were of mild to moderate intensity. Paroxetine is effective and well tolerated in Japanese adult patients with obsessive-compulsive disorder.
Topics: Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Japan; Male; Middle Aged; Obsessive-Compulsive Disorder; Paroxetine; Personality Inventory; Psychometrics; Selective Serotonin Reuptake Inhibitors; Treatment Outcome
PubMed: 15298657
DOI: 10.1111/j.1440-1819.2004.01278.x -
The Journal of Neuropsychiatry and... 2007
Topics: Aged, 80 and over; Antidepressive Agents, Second-Generation; Bruxism; Depressive Disorder; Humans; Isoindoles; Male; Paroxetine; Piperazines; Pyrimidines; Serotonin Receptor Agonists
PubMed: 17308240
DOI: 10.1176/jnp.2007.19.1.90 -
The American Journal of Psychiatry Feb 2000The purpose of this study was to determine the extent of infant medication exposure through breast-feeding during maternal treatment with paroxetine. (Comparative Study)
Comparative Study
OBJECTIVE
The purpose of this study was to determine the extent of infant medication exposure through breast-feeding during maternal treatment with paroxetine.
METHOD
Breast milk and paired maternal and infant sera were collected after 10 days of maternal treatment with paroxetine at a stable daily dose (10-50 mg/day). All samples were analyzed by means of high-performance liquid chromatography with ultraviolet detection and a limit of detection of 2 ng/ml.
RESULTS
Breast milk paroxetine concentrations were highly variable (2-101 ng/ml) and were present in all breast milk samples (N=108). A significant gradient effect was observed, with greater paroxetine concentrations found in later portions of breast milk (hind milk) than in early portions (fore milk). No clear time course of paroxetine excretion into breast milk was demonstrated, although maternal paroxetine daily dose reliably predicted both trough and peak breast milk concentrations over a 24-hour period. In 16 mother and infant serum pairs, no detectable concentrations of paroxetine were found in the serum of the nursing infants.
CONCLUSIONS
This study extends previous data by demonstrating the presence of paroxetine in the breast milk of nursing women treated with this medication. The low concentrations of paroxetine in infant serum and lack of any observable adverse effects after maternal use of this medication while breast-feeding parallels the available data on other selective serotonin reuptake inhibitors.
Topics: Breast Feeding; Chromatography, High Pressure Liquid; Depressive Disorder; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Infant, Newborn; Milk, Human; Paroxetine; Pregnancy; Puerperal Disorders
PubMed: 10671385
DOI: 10.1176/appi.ajp.157.2.185