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

NCT01153347

D4130C00004

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.

Enrollment: 2,409 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.
• Outpatient 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 investigational product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,409 participants in 4 patient groups, including a placebo group

SSRI/Serotonin/SNRI+ TC-5214 0.5 mg

Experimental group

Description:

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID

Treatment:

Drug: TC-5214

SSRI/Serotonin/SNRI + TC-5214 2 mg

Experimental group

Description:

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID

Treatment:

Drug: TC-5214

SSRI/Serotonin/SNRI + TC-5214 4 mg

Experimental group

Description:

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

Treatment:

Drug: TC-5214

SSRI/Serotonin/SNRI + Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo