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
• 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
• Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
  Status: Recruiting, Condition Summary: Major Depressive Disorder (MDD)
• 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):

A comparative study of non-fatal self-poisoning with antidepressants relative to prescribing in three centres in England.

J Affect Disord. 2009 Oct 26;
Bergen H, Murphy E, Cooper J, Kapur N, Stalker C, Waters K, Hawton K
BACKGROUND: Antidepressants are used frequently in non-fatal self-poisoning. There are national guidelines for prescribing antidepressants. There have been few investigations of how non-fatal self-poisoning with antidepressants varies in relation to prescribing and to patient characteristics. METHODS: A comparative study of the use of specific antidepressants (amitriptyline and dosulepin (tricyclics), citalopram, fluoxetine, paroxetine and sertraline (selective serotonin reuptake inhibitors) and venlafaxine (serotonin norepinephrine reuptake inhibitor)) for non-fatal self-poisoning (episode-based), relative to prescribing, in three centres in England, 2004 to 2006. RESULTS: There was marked variation between centres in the ratio of rates of self-poisoning to prescribing for specific antidepressants. Higher rates of self-poisoning relative to prescribing for all antidepressants combined, and for venlafaxine, were found in the centre with greater proportions of patients with a history of self-harm and/or previous psychiatric treatment. Within each centre, higher rates of self-poisoning relative to prescribing were found for citalopram and fluoxetine than amitriptyline. However, rates of self-poisoning relative to prescribing for either amitriptyline or dosulepin were also similar to sertraline, which is of concern given the known toxicity of tricyclics. LIMITATIONS: An ecological study, where prescriptions were for all indications and not specifically for the patients who self-poisoned. CONCLUSIONS: Marked differences found in ratios of self-poisoning with antidepressants to levels of prescribing, in three centres in England, are likely to reflect differences in both prescribing practices (despite clear national guidance) and patient characteristics. Risk of overdose and toxicity should be considered when local prescribing policy and clinical practice relating to antidepressants are under review.

Gestational Exposure to Antidepressants and the Risk of Spontaneous Abortion: A Review.

Curr Drug Deliv. 2009 Oct 29;
Broy P, Bérard A
Background. Although the relationship between antidepressant use during pregnancy and its adverse effects has been widely investigated, very few studies have evaluated the impact of antidepressant use during pregnancy on the risk of spontaneous abortion. We present an overview of the evidence relating to the association between antidepressant use during gestation and the risk of spontaneous abortion. Methods. We systematically searched PubMed and the reference lists of all relevant articles, including reviews, published in English or French from 1975 through 2009 for studies that examined the association between adverse pregnancy outcomes and gestational exposure to antidepressants with data on spontaneous abortions. Only etiologic studies were considered. Results. Fifteen studies met inclusion criteria. The majority of these were prospective cohort studies on tricyclics antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs) use during pregnancy. Overall, in unadjusted analyses, fluoxetine (OR = 2.0; 95% CI = 1.4 - 3.0) and bupropion (OR = 4.1; 95% CI = 1.5 - 11.1) were significantly associated with the risk of spontaneous abortion. However, in adjusted analyses, only paroxetine (OR = 1.7; 95% CI = 1.3 - 2.3) and venlafaxine (OR = 2.1; 95% CI = 1.3 - 3.3) were significantly associated with the risk of spontaneous abortion. Conclusions. This review suggests that gestational exposure to antidepressants, especially paroxetine and venlafaxine, can lead to spontaneous abortion.

Use of antidepressants for management of hot flashes.

Pharmacotherapy. 2009 Nov; 29(11): 1357-74
Carroll DG, Kelley KW
A growing body of evidence suggests that antidepressant therapies, particularly selective serotonin reuptake inhibitors and venlafaxine, are effective in the management of hot flash symptoms. Several of these agents have the support of the American College of Obstetricians and Gynecologists and the North American Menopause Society. To review the literature on antidepressants for the treatment of hot flashes in women, we searched the PubMed, International Pharmaceutical Abstracts, and MEDLINE databases from inception through May 2009. All publication types that included human participants and that were published in English were eligible for review. These articles, relevant abstracts, and additional references were used to collect pertinent data. Although initial small pilot trials were conducted solely in breast cancer survivors, additional studies have been conducted both in breast cancer survivors and in relatively healthy menopausal women. Data on the benefits with many of these agents are conflicting. Venlafaxine and paroxetine have been studied more extensively than any of the other antidepressants and are more consistent in effectively reducing the frequency and severity of hot flashes, based on these study results. Desvenlafaxine, sertraline, fluoxetine, and citalopram should be considered second- or third-line options if patients fail therapy with or cannot tolerate venlafaxine or paroxetine, based on the current published data. Duloxetine, escitalopram, fluvoxamine, and mirtazapine should be reserved as last-line therapy until more rigorous studies are conducted assessing their use in the management of hot flashes.

[Comparative efficacy and acceptability of new-generation antidepressants. Synthesis meta-analysis "Cipriani"]

Encephale. 2009 Oct; 35(5): 499-504
Gaillard R
Conventional meta-analyses have shown inconsistent results for efficacy of new-generation antidepressants. The authors therefore did a multiple-treatments meta-analysis, which accounts for both direct and indirect comparisons, to assess the effects of 12 of these antidepressants. They systematically reviewed 117 randomised controlled trials (25,928 participants), which compared any of the following antidepressants for the acute treatment of unipolar major depression in adults: bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, and venlafaxine. The main outcomes were the proportion of patients who responded to or dropped out of the allocated treatment. Analysis was done on an intention-to-treat basis. Mirtazapine, escitalopram, venlafaxine, and sertraline were significantly more efficacious than duloxetine, fluoxetine, fluvoxamine, paroxetine, and reboxetine. Escitalopram and sertraline showed the best profile of acceptability, leading to significantly fewer discontinuations than did duloxetine, fluvoxamine, paroxetine, reboxetine, and venlafaxine. Clinically important differences exist between commonly prescribed antidepressants for both efficacy and acceptability in favour of escitalopram and sertraline.

Effects of Selective Serotonin Reuptake Inhibitor on Treating Tinnitus in Patients Stratified for Presence of Depression or Anxiety.

Audiol Neurootol. 2009 Oct 23; 15(3): 187-193
Oishi N, Kanzaki S, Shinden S, Saito H, Inoue Y, Ogawa K
We evaluated the effects of a selective serotonin reuptake inhibitor, paroxetine, on treating tinnitus.Tinnitus patients stratified for the presence of depression and anxiety were studied retrospectively. Fifty-six patients were observed for more than 6 months. They were initially treated with paroxetine only at a dose of 10 mg/day for 2-4 weeks; thereafter, the dose was increased to 20 mg/day. Tinnitus distress was evaluated with the Tinnitus Handicap Inventory (THI) and with visual analog scales (VASs) for tinnitus loudness and annoyance. Depression and anxiety were measured with the Self-Rating Depression Scale (SDS) and the trait section of the State-Trait Anxiety Inventory (STAI). The patients were grouped according to their SDS and STAI scores, and each variable was compared at baseline and the 6-month follow-up. Changes among these variables were also examined to determine whether reduced tinnitus distress was related to the improvement of depression or anxiety. Patients with both depression and anxiety showed better results (decrease in THI, VASs, SDS and STAI scores) than patients with anxiety alone, or patients without depression and anxiety. In patients with depression and anxiety, changes in tinnitus variables and changes in depression and anxiety scores were strongly correlated. In other patients, however, changes in tinnitus variables and changes in depression and anxiety scores were not correlated. These results suggest that paroxetine is effective in treating distressed tinnitus patients with depression and anxiety by reducing their tinnitus severity as well as their depression and anxiety.