Health Condition 1: null- Major Depressive Disorder
Conditions
Interventions
Intervention1: TC-5214, 1mg BID: Tablet, oral, twice daily for 8 weeks
Intervention2: TC-5214, 4mg BID: Tablet, oral, twice daily for 8 weeks
Intervention3: TC-5214, 4mg BID: Tablet, oral, twice dail
Sponsors
AstraZeneca AB
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in clinician rated symptoms as assessed by Clinical Global Impression-Improvement (CGI-I)Timepoint: Range of weeks 8 (baseline) to 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs)(any incidence) and Serious Adverse Events (SAEs), will be assessed as a measure of safety and tolerability.Timepoint: Range of weeks 8 (baseline) to 16.;Change in physical exam results, vital signs, lab tests (incl. ECG (electrocardiogram) will be assessed.Timepoint: Range of weeks 1-18;Changes in clinician rated symptoms as assessed by Clinical Global Impression-Severity (CGI-S)Timepoint: Range of weeks 8 (baseline) to 16.;Changes in clinician rated symptoms as assessed by Hamilton Rating Scale for Depression (HAMD).Timepoint: Range of weeks 8 (baseline) to 16;Changes in clinician rated symptoms as assessed by MADRSTimepoint: Range of weeks 8 (baseline) to 16;Changes in patient-reported outcomes as assessed by Sheehan Disability Scale (SDS)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
Outcome results
None listed