A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder

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 With an Inadequate Response to Antidepressant Therapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/06/002750

Enrollment

352

Registered

2012-06-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Major Depressive Disorder

Interventions

Intervention1: TC-5214 : 4 mg BID, Tablet, oral, twice daily for 8 weeks Intervention2: TC-5214: 1mg BID, Tablet, oral, twice daily for 8 weeks Control Intervention1: Placebo: oral, twice daily for

Eligibility

Inclusion criteria

Inclusion criteria: 1. Provision of signed and dated informed consent before initiation of any study-related procedures. 2. The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant. 3. Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug. 4.Outpatient status at enrollment and randomization.

Exclusion criteria

Exclusion criteria: 1. Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder. 2. 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. 3. History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population

Design outcomes

Primary

Measure	Time frame
Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16)Timepoint: Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16)	—

Secondary

Measure	Time frame
Changes in clinician rated symptoms as assessed by Montgomery Asberg Depression Rating Scale (MADRS)Timepoint: Range of weeks 8 (baseline) to 16	—

Countries

Estonia, Finland, India, Japan, United States of America

Contacts

Public ContactSuneela Thatte

Quintiles Research (India) Pvt Ltd

gaurav.mathur@quintiles.com917966303355

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026