FindTrial
Sign In

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221501
Enrollment
Unknown
Registered
2011-06-30
Start date
2011-06-30
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Major Depressive Disorder

Interventions

investigational material(s) Generic name etc : TC-5214 INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : o

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. - 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. - Outpatient status at enrollment and randomization.

Exclusion criteria

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. - Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation. - History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury. - Pregnancy or lactation.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026