OBJECTIVE This is an analysis of the unpublished continuation phase of Study 329, the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The objectives of the continuation phase were to assess safety and relapse rates in the longer term. The objective of this publication, und...

OBJECTIVE Two phase 3, randomized, placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms (VMS) associated with menopause and had a favorable tolerability profile. The impact of paroxetine 7.5 mg on body weight and sexual function was evaluated in a pooled analysis. METHODS Postmenopausal women aged 40 years or older who...

OBJECTIVE Panic disorder (PD) is a common and often chronic psychiatric illness, and serotonin-specific reuptake inhibitors (SSRIs) are the drugs of choice for the treatment of PD. Previous studies suggested the cerebral cortex and limbic brain structures played a major role in the development of PD, but the therapeutic effect of SSRIs on specific brain structures remains unclear in PD. We exam...

PURPOSE To investigate the association between the 5-HT-transporter-gene-linked promoter region (5-HTTLPR) polymorphism and 20-mg paroxetine-induced ejaculation delay in men with lifelong premature ejaculation (LPE). MATERIALS AND METHODS This was a prospective study of 10 weeks of paroxetine treatment in 54 men with LPE. Intravaginal ejaculation latency time (IELT) was measured by stopwatch....

BACKGROUND Posttraumatic stress disorder (PTSD) is a very debilitating disease refractory to current treatment with selective serotonin reuptake inhibitors (SSRIs) in up to 30 percent of patients, illustrating the need for new treatments of PTSD. Neuroimaging studies have shown increased activity of the amygdala of patients with PTSD. OBJECTIVE/HYPOTHESIS To investigate amygdala deep brain st...

Several administrative database studies have reported on a positive association between first trimester exposure to paroxetine and ventricular septal defects (VSD). Using multiple source data we have shown that depressed women utilize significantly more health care resources, including ultrasound, echocardiogram and emergency room visits for their babies. Hence, there is much higher chance to i...

Depression is associated with abnormal functions of the immune system. In this study, we investigated how two modem antidepressant therapies, chronic treatment with transcranial magnetic stimulation (TMS) and administration of an antidepressant belonging to selective serotonin reuptake inhibitors (SSRI), paroxetine, affect the proliferative response of thymocytes and splenocytes stimulated in v...

M e t h o d s Design: Randomized, 2 × 2 factorial design, placebo-controlled trial. Allocation: {Concealed}†.* Blinding: Blinded (clinicians, patients, and outcome assessors).* Clinicians and patients were not blinded to the psychotherapy intervention. Follow-up period: 2 years. Setting: Specialized university-based clinic in Pittsburgh, Pennsylvania, USA. Patients: 116 patients ≥ 70 years of a...

Selective reporting is prevalent in the medical literature, particularly in industry-sponsored research. In this paper, we expose selective reporting that is not evident without access to internal company documents. The published report of study 329 of paroxetine in adolescents sponsored by GlaxoSmithKline claims that “paroxetine is generally well tolerated and effective for major depression in...

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential....