Track topics on Twitter Track topics that are important to you
The purpose of this study is to evaluate the efficacy, safety and tolerability of Lu AA21004, once daily (QD), compared with placebo in adults with major depressive disorder.
Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder (MDD) is among the most important causes of disability worldwide, in both developing and developed countries. Major depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Major depressive disorder is characterized by the presence of 1 or more major depressive episodes that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration.
Studies suggest that at least 70% of depressed patients also report somatic symptoms such as pain, shortness of breath, fatigue, or nausea. A number of patients may present with somatic symptoms as the main complaint rather than depressed mood. Depression is recurrent in 75% to 80% of patients, becomes chronic (ie, lasting 2 years or longer) in 15% to 20% of depressed patients, and can lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. Furthermore, depression may lead to suicide and the mortality due to suicide is approximately 15% among patients treated by psychiatrists. Major depressive disorder imposes a socioeconomic burden comparable to chronic medical illnesses in terms of healthcare utilization, decreased productivity, and dysfunctional family life, and is associated with an increased consumption of general medical, psychiatric and emergency services.
Lu AA21004 is a compound under development by Takeda Pharmaceutical Company Limited and H. Lundbeck A/S with clinical development for the treatment of major depressive disorder.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Depressive Disorder, Major
Lu AA21004, Lu AA21004, Duloxetine, Placebo
Not yet recruiting
Takeda Global Research & Development Center, Inc.
Published on BioPortfolio: 2014-08-27T03:12:36-0400
The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Lu AA21004 in order to establish the appropriate clinical effective dose range in the trea...
The purpose of this study is to determine the efficacy and safety of Lu AA21004, once daily (QD), in adults with major depressive disorder.
The purpose of the study is to evaluate the efficacy and the safety of two fixed doses of Lu AA21004 in the treatment of Major Depressive Disorder.
The purpose of this study is to determine the effectiveness and safety of Lu AA21004, once daily (QD), in patients with Major Depressive Disorder.
The purpose of the study is to evaluate the efficacy and the tolerability of two fixed doses of Lu AA21004 in the acute treatment of Major Depressive Disorder.
This randomized, placebo-controlled, crossover trial examined the antidepressant efficacy of the muscarinic antagonist scopolamine in major depressive disorder subjects with more severe and refractory...
This study compared the efficacy and safety of aripiprazole/sertraline combination (ASC) and placebo/sertraline combination (PSC) in patients with major depressive disorder (MDD) who showed an inadequ...
The present placebo-controlled study evaluated the efficacy and safety of 8 weeks of treatment with tianeptine 25-50 mg/d in elderly patients suffering from major depressive disorder (MDD) according t...
The purpose of this work is to investigate the effect of agomelatine on functioning compared with placebo in patients suffering from Major Depressive Disorder (MDD).
Experimental studies provide evidence for antidepressant effects of Palmitoylethanolamide (PEA) in animal models of depression. We aimed to evaluate the efficacy and tolerability of PEA add-on therapy...
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
Inability to experience pleasure due to impairment or dysfunction of normal psychological and neurobiological mechanisms. It is a symptom of many PSYCHOTIC DISORDERS (e.g., DEPRESSIVE DISORDER, MAJOR; and SCHIZOPHRENIA).
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.
Depression is a serious mental health condition, where sad feelings carry on for weeks or months and interfere with your life. The symptoms include feeling unhappy most of the time (but may feel a little better in the evenings), loosing interest in lif...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...