ABSTRACT
The incidence of treatment-emergent sexual dysfunction in the acute and continuation phases of the prevention of recurrent episodes of depression with venlafaxine ER for two years (PREVENT) study was assessed. Adult outpatients with recurrent major depressive disorder were randomly assigned to receive venlafaxine extended release (ER; 75-300 mg/day) or fluoxetine (20-60 mg/day). Sexual dysfunction was assessed using items from the 17-item Hamilton Rating Scale for Depression (HAM-D(17)) and the Inventory of Depressive Symptomatology-Self-Report (IDS-SR). The baseline rates of sexual dysfunction based on the HAM-D(17) and IDS-SR items were 57.9% and 48.8%, respectively. The rates of new-onset sexual dysfunction for the venlafaxine ER-treated (44.8%, HAM-D(17); 38.4%, IDS-SR) and fluoxetine-treated patients (52.9%, HAM-D(17); 50.0%, IDS-SR) were similar; approximately 80% of the cases resolved during treatment. Treatment response was associated with lower rates of new-onset sexual dysfunction compared with nonresponse. The patients who remitted were the least likely to experience sexual dysfunction during antidepressant treatment.
Subject(s)
Antidepressive Agents, Second-Generation/adverse effects , Antidepressive Agents, Second-Generation/therapeutic use , Cyclohexanols/adverse effects , Cyclohexanols/therapeutic use , Depressive Disorder, Major/drug therapy , Fluoxetine/adverse effects , Fluoxetine/therapeutic use , Sexual Dysfunction, Physiological/chemically induced , Adolescent , Adult , Aged , Aged, 80 and over , Depressive Disorder, Major/diagnosis , Depressive Disorder, Major/psychology , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , Personality Inventory/statistics & numerical data , Psychometrics , Secondary Prevention , Sexual Dysfunction, Physiological/diagnosis , Sexual Dysfunction, Physiological/psychology , Treatment Outcome , United States , Venlafaxine Hydrochloride , Young AdultABSTRACT
Currently, the primary efficacy measures for antidepressant clinical trials predominantly assess changes in mood symptoms in patients with major depressive disorder (MDD). When considering treatment options, however, patients and clinicians value improvement in function in important life domains as highly as symptom reduction. MDD patients report that they consider a return to normal functioning an important indicator of remission from depressive episodes. Indeed, many researchers now regard assessment of both mood symptoms and functional outcomes essential to measuring treatment-related improvement and remission from MDD. However, function is a very broad concept. Investigators must consider multiple issues in designing or selecting an instrument that measures function adequately and appropriately in their particular study population. The assessment tool should include dimensions of functioning that are relevant and likely to improve with the treatment, and the instrument should have demonstrated reliability and validity, good discrimination among patients, and sensitivity to meaningful improvement in functioning. The inclusion of well-chosen functional outcome measures in clinical trials will improve the assessment of impairment and improvement with treatment, and provide patients and clinicians with important information about the efficacy of antidepressant treatments.
Subject(s)
Depressive Disorder, Major/rehabilitation , Disability Evaluation , Recovery of Function , Surveys and Questionnaires , Depressive Disorder, Major/drug therapy , Depressive Disorder, Major/physiopathology , Humans , Treatment OutcomeABSTRACT
Many academics, clinicians and lay readers of science incorrectly assume that vomeronasal processing is equivalent to pheromone processing. We review the abundant data concerning the roles of both the olfactory and the vomeronasal systems in the processing of both pheromones and other odorants, demonstrating that this "equivalency hypothesis" is untenable. This conclusion has important implications for the design and interpretation of experiments examining vomeronasal and olfactory system function. We describe some of the problems that arise from assuming that this equivalency holds. Two alternative hypotheses have been offered, but the available data do not enable us to accept or reject either one. Perhaps no single functional description can adequately characterize the role of the vomeronasal system.
