EUCTR2010-019925-33-DEActive, not recruitingNot Applicable
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 940
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Provision of signed and dated informed consent before initiation of any study-related procedures.
- •The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
- •Out-patient status at enrollment and randomization.
- •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 893
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 47
Exclusion Criteria
- •Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
- •Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a signficant history of risk of suicide or homicide.
- •History of renal insufficiency or impairment or conditions that could affect absorption or metabilism of the investigationl product in this patient population
Investigators
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