Adjunct treatment to an antidepressant in patients with Major Depressive Disorder who exhibit an inadequate response to antidepressant therapy MedDRA version: 13.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 13.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: TC-5214 (S-mecamylamine)
Product Code: TC-5214 (S-mecamylamine)
Pharmaceutical Form: Tablet
CAS Number: 107596-30-5
Current Sponsor code: TC-5214-23
Other descriptive name: S(+)-Mecamyla
Sponsors
AstraZeneca AB
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. 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of TC-5214 compared with placebo as an adjunct to antidepressant (selective serotonin reuptake inhibitor [SSRI]/serotonin/norepinephrine reuptake inhibitor [SNRI]) therapy in patients with major depressive disorder (MDD) who exhibit an inadequate response to antidepressant therapy, as assessed by change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16). Safety objectives: To evaluate the safety and tolerability of TC-5214 and placebo as an adjunct to an antidepressant (SSRI/SNRI) in patients with MDD who exhibit an inadequate response to antidepressant therapy.;Secondary Objective: To evaluate the efficacy of TC-5214 compared with placebo as an adjunct to an antidepressant (SSRI/SNRI) in patients with MDD who exhibit an inadequate response to antidepressant therapy as assessed by depressive symptoms, clinical global outcome regarding severity and improvement and anxiety, and also as assessed by patient-reported outcomes (PROs) regarding functional impairment and overall quality of life and severity of depressive symptoms. To investigate pharmacokinetic (PK) properties of TC-5214 in patients with MDD using a population PK analysis methodology. These results will be reported separately from the primary and other secondary objectives. Change in overall quality of life and satisfaction from randomization (Week 8) to end of treatment (Week 16) in Q-LES-Q-SF, items 15 and 16 Change in health-related quality of life as measured by the EuroQol VAS and 5 dimensions (EQ-5D) from randomization (Week 8) to end of treatment (Week 16) ;Primary end point(s): Primary efficacy variable: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16);Timepoint(s) of evaluation of this end point: Will be scored at Weeks 8 (baseline), 9, 10, 12, 14 and 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in clinician-rated symptoms as assessed by MADRS, HAM-D, CGI-S, and CGI-I Changes in patient-reported outcomes as assessed by SDS and Q-LES-Q-SF AEs, SAEs, change in physical exam results and vital signs, laboratory tests and ECG, C-SSRS, BARS and AIMS, CSFQ, and DESS will be assessed as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: MADRS and CGI will be scored at Weeks 8 (baseline), 9, 10, 12, 14 and 16; HAM-D will be scored at Weeks 8 (baseline) and 16 Will be analysed at Weeks 8, 12 and 16 for SDS and Weeks 8 and 16 for Q-LES-Q-SF Time consent signed (enrollment, 2 wk screening/washout period), during 8-wk prospective open-label period, during 8-wk randomized double-blind period, and during 2-wk follow up period. Unsolicited SAEs collected 30 days post last treatment | — |
Countries
Czech Republic, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, Sweden
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed