A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder; Depression

Treatments: Drug: TC-5214; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01180400

D4130C00003

Details and patient eligibility

About

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Full description

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

Enrollment: 295 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

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 significant history of risk of suicide or homicide.
• History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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295 participants in 2 patient groups, including a placebo group

TC-5214

Experimental group

Description:

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID

Treatment:

Drug: TC-5214

Placebo

Placebo Comparator group

Description:

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID

Treatment:

Drug: Placebo