A phase I, multi-centre, double-blind, placebo-controlled parallel group study to assess the pharmacoMRI effects of AZD6765 in male and female patients fulfilling the criteria for Major Depressive Disorder

AstraZeneca AB0 个研究点开始时间: 2009年7月23日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Female or male subjects aged 18-45 years, inclusive at enrolment.
•2. Women of child bearing potential must have a negative serum pregnancy test and confirmed (by the Investigator) use of a highly effective form of birth control.
•3. Documented clinical diagnosis meeting criteria from the DSM-IV by structured clinical interview (SCID) for any of the following
•296.2x Major Depressive Disorder, Single Episode, or
•296.3x Major Depressive Disorder, Recurrent
•4. Outpatient status at screening and randomisation.
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Subjects with a DSM IV Axis II disorder which has a major impact on the subjects current psychiatric status.
•2. Subjects with lifetime history of schizophrenia, bi-polar, psychosis and psychotic depression.
•3. Subjects’ use of mood stabilizers, antidepressants or other antipsychotic or psychoactive drugs within 14 days of Visit 2.
•4. Subjects with a positive urine toxicology at screening (UTS) or at Visit 2 for cocaine and/or metabolites, amphetamines, opiates, phencyclidine (PCP), and barbiturates will be excluded except for subjects testing positive for prescribed medications. Subjects can be re-tested if the UTS is positive, but should be excluded if the results are still positive.
•5. OTC medicine within 48 hours prior to Visit 2. Subjects who have taken OTC medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
•6. Use of any medications that could confound MRI signal per judgement of Investigator.
•7. Pregnancy or lactation.

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