Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

NCT01323478 | Completed Phase 3 Results

• 2 other identifiers: 13267B2010-024198-38
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

Conditions

Major Depressive Disorder

Keywords

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioural Symptoms

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Adverse Events (AEs)

  Baseline to end of the 4-week safety follow-up period

• Percentage of Patients Who Withdrew Due to Intolerance to Treatment

  Baseline to Week 52

Secondary Outcomes (8)

• Change From Baseline in MADRS Total Score After 52 Weeks of Treatment

  Baseline and Week 52

• Change From Baseline in CGI-S Score After 52 Weeks of Treatment

  Baseline and Week 52

• Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment

  Baseline and Week 52

• Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)

  Baseline from lead-in study 13267A (NCT01140906) and Week 52

• Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)

  Baseline and Week 52

Study Arms (1)

Vortioxetine

EXPERIMENTAL

Drug: Vortioxetine (Lu AA21004)

Interventions

Vortioxetine (Lu AA21004) DRUG

15 or 20 mg/day; tablets; orally

Also known as: Brintellix

Vortioxetine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study

You may not qualify if:

• 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
• The patient, in the investigator's clinical judgment, has a significant risk of suicide.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Related Publications (1)

• Mattingly GW, Necking O, Schmidt SN, Reines E, Ren H. Long-term safety and efficacy, including anhedonia, of vortioxetine for major depressive disorder: findings from two open-label studies. Curr Med Res Opin. 2023 Apr;39(4):613-619. doi: 10.1080/03007995.2023.2178082. Epub 2023 Mar 8.

  PMID: 36884024 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder; Depression; Mood Disorders; Mental Disorders; Behavioral Symptoms

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+45 3630 1311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 11, 2014
• Results First Posted: February 11, 2014

Record last verified: 2013-12