Trial Outcomes & Findings for Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults (NCT NCT00761306)

NCT ID: NCT00761306

Last Updated: 2014-01-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 74 participants
• Primary outcome timeframe: Up to 52 weeks and a 4-week safety follow-up period
• Results posted on: 2014-01-29

Participant Flow

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.

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.

Participant milestones

Measure	Vortioxetine 5 or 10 mg/Day tablets; orally
Overall Study STARTED	74
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	Vortioxetine 5 or 10 mg/Day tablets; orally
Overall Study Adverse Event	5
Overall Study Lack of Efficacy	4
Overall Study Protocol Violation	2
Overall Study Withdrawal of Consent	3
Overall Study Lost to Follow-up	1
Overall Study Administrative or Other Reasons	5

Baseline Characteristics

Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

Baseline characteristics by cohort

Measure	Vortioxetine 5 or 10 mg/Day n=74 Participants tablets; orally
Age, Continuous	44.5 years STANDARD_DEVIATION 11.5 • n=93 Participants
Sex: Female, Male Female	45 Participants n=93 Participants
Sex: Female, Male Male	29 Participants n=93 Participants
MADRS	10.7 units on a scale STANDARD_DEVIATION 8.4 • n=93 Participants
HAM-D-24	10.2 units on a scale STANDARD_DEVIATION 7.8 • n=93 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks and a 4-week safety follow-up period

Population: APTS

Outcome measures

Measure	Vortioxetine 5 or 10 mg/Day n=74 Participants tablets; orally
Number of Patients With Adverse Events (AEs) Patients With AEs	64 participants
Number of Patients With Adverse Events (AEs) Patients With SAEs	1 participants
Number of Patients With Adverse Events (AEs) Patients With AEs Leading to Withdrawal	5 participants
Number of Patients With Adverse Events (AEs) Patients With Baseline Events	16 participants

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: APTS

Outcome measures

Measure	Vortioxetine 5 or 10 mg/Day n=74 Participants tablets; orally
Percentage of Patients Who Withdrew Due to Intolerance to Treatment	6.8 percentage of patients

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS; observed cases (OC)

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.

Outcome measures

Measure	Vortioxetine 5 or 10 mg/Day n=55 Participants tablets; orally
Change From Baseline in MADRS Total Score After 52 Weeks of Treatment	-4.33 units on a scale Standard Deviation 9.24

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS; OC

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.

Outcome measures

Measure	Vortioxetine 5 or 10 mg/Day n=59 Participants tablets; orally
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 outcome

Timeframe: Week 52

Population: FAS; OC

Outcome measures

Measure	Vortioxetine 5 or 10 mg/Day n=55 Participants tablets; orally
Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)	92.7 percentage of patients

SECONDARY outcome

Timeframe: Week 52

Population: FAS; OC

Outcome measures

Measure	Vortioxetine 5 or 10 mg/Day n=55 Participants tablets; orally
Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)	81.8 percentage of patients

Adverse Events

Vortioxetine 5 or 10 mg/Day

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vortioxetine 5 or 10 mg/Day n=74 participants at risk
Endocrine disorders Thyroiditis	1.4% 1/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period

Other adverse events

Measure	Vortioxetine 5 or 10 mg/Day n=74 participants at risk
Gastrointestinal disorders Diarrhoea	8.1% 6/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
Gastrointestinal disorders Nausea	27.0% 20/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
General disorders Fatigue	6.8% 5/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
Infections and infestations Gastroenteritis	5.4% 4/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
Infections and infestations Nasopharyngitis	23.0% 17/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
Investigations Weight increased	18.9% 14/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
Nervous system disorders Dizziness	6.8% 5/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
Nervous system disorders Headache	13.5% 10/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
Psychiatric disorders Insomnia	6.8% 5/74 • Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period

Additional Information

H. Lundbeck A/S

H. Lundbeck A/S

Phone: +45 3630 1311

Email: LundbeckClinicalTrials@lundbeck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The main publication has to be published before any sub-publications. H. Lundbeck A/S follows the Vancouver declaration with respect to authorship.
• Publication restrictions are in place

Restriction type: OTHER