Efficacy of add-on pregabalin in the treatment of Generalized Anxiety Disorder comorbid with Major Depressive Disorder: a double-blind placebo-controlled study.

Aristotle University of Thessaloniki0 个研究点目标入组 60 人开始时间: 2013年5月22日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•1. Generalized Anxiety Disorder (GAD) according to DSM-IV-TR diagnostic criteria
•2. Major Depressive episode (MD) according to DSM-IV-TR diagnostic criteria
•3. Patients already receiving esitalopram.
•4. Male or female patients, aged between 18-65 years of age
•5. Signed and dated patients’ informed consent received from patients who are able to understand and comply with study requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Any other comorbid condition
•2. Abuse of alcohol or other substances at screening (excepting dependence being in total remission; excepting dependence on caffeine or nicotine), according to DSM-IV criteria
•3. Abuse of substances such as opiates, amphetamines, barbiturates, cocaine, cannabis, hallucinogens for a duration of four weeks before screening day, according to DSM-IV criteria
•4. Any DSM-IV-TR-defined psychic disorder that may affect the interpretation of results
•5. Female patients of reproductive age who do not apply any reliable contraceptive method and do not have a negative human chorionic gonadotropin (HCG) value at screening
•6. Patients who are in severe danger of suicide, or represent a danger to themselves and others in the investigator’s judgment
•7. Known hypersensitivity or lack of responsiveness to the trial drugs in the investigator’s judgment.

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