Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, Long-term, Safety, Open-label
Brief summary
The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A.
Interventions
5 or 10 mg/day; tablets; orally
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Patients who completed 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period
Exclusion criteria
* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV TR) * Female patients of childbearing potential who are not using effective contraception * Use of any psychoactive medication Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Adverse Events (AEs) | Up to 52 weeks and a 4-week safety follow-up period |
| Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Baseline to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in MADRS Total Score After 52 Weeks of Treatment | Baseline and Week 52 | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. |
| Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment | Baseline and Week 52 | The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. |
| Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) | Week 52 | — |
| Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) | Week 52 | — |
Participant flow
Recruitment details
Patients eligible to participate in present study, NCT00761306 / 11492C, were outpatients, who had completed lead-in study NCT00839423 / 11492A immediately prior to inclusion into present study.
Pre-assignment details
The study consisted of a 1-week, fixed-dose period with Vortioxetine 10 mg/day, a 51-week flexible dose period with Vortioxetine 5 or 10 mg/day, and a 4-week safety follow up period.
Participants by arm
| Arm | Count |
|---|---|
| Vortioxetine 5 or 10 mg/Day tablets; orally | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative or Other Reasons | 5 |
| Overall Study | Adverse Event | 5 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal of Consent | 3 |
Baseline characteristics
| Characteristic | Vortioxetine 5 or 10 mg/Day |
|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 11.5 |
| HAM-D-24 | 10.2 units on a scale STANDARD_DEVIATION 7.8 |
| MADRS | 10.7 units on a scale STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 74 |
| serious Total, serious adverse events | 1 / 74 |
Outcome results
Primary
Number of Patients With Adverse Events (AEs)
Time frame: Up to 52 weeks and a 4-week safety follow-up period
Population: APTS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vortioxetine 5 or 10 mg/Day | Number of Patients With Adverse Events (AEs) | Patients With AEs Leading to Withdrawal | 5 participants |
| Vortioxetine 5 or 10 mg/Day | Number of Patients With Adverse Events (AEs) | Patients With Baseline Events | 16 participants |
| Vortioxetine 5 or 10 mg/Day | Number of Patients With Adverse Events (AEs) | Patients With AEs | 64 participants |
| Vortioxetine 5 or 10 mg/Day | Number of Patients With Adverse Events (AEs) | Patients With SAEs | 1 participants |
Primary
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Time frame: Baseline to Week 52
Population: APTS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vortioxetine 5 or 10 mg/Day | Percentage of Patients Who Withdrew Due to Intolerance to Treatment | 6.8 percentage of patients |
Secondary
Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Time frame: Baseline and Week 52
Population: FAS; OC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vortioxetine 5 or 10 mg/Day | Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment | -3.46 units on a scale | Standard Deviation 8.72 |
Secondary
Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
Time frame: Baseline and Week 52
Population: FAS; observed cases (OC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vortioxetine 5 or 10 mg/Day | Change From Baseline in MADRS Total Score After 52 Weeks of Treatment | -4.33 units on a scale | Standard Deviation 9.24 |
Secondary
Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
Time frame: Week 52
Population: FAS; OC
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vortioxetine 5 or 10 mg/Day | Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) | 81.8 percentage of patients |
Secondary
Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
Time frame: Week 52
Population: FAS; OC
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vortioxetine 5 or 10 mg/Day | Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) | 92.7 percentage of patients |