Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

NCT00596817 | Completed Phase 3 Results

• 2 other identifiers: 11985A2007-001871-13
• Study Type: interventional
• Target: 639
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.

Conditions

Major Depressive Disorder

Keywords

Relapse prevention; Antidepressants; Placebo-controlled; Double-blind; Multicentre study

Outcome Measures

Primary Outcomes (1)

• Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator

  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.

  Within first 24 weeks of the double-blind period

Secondary Outcomes (8)

• Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator

  Within 64 weeks of the double-blind period

• Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment

  Double-blind Baseline and Week 24 of the double-blind period

• Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment

  Double-blind Baseline and Week 24 of the double-blind period

• Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment

  Double-blind Baseline and Week 24 of the double-blind period

• Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment

  Double-blind Baseline and Week 24 of the double-blind period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Vortioxetine: 5 or 10 mg

EXPERIMENTAL

Drug: Vortioxetine (Lu AA21004)

Interventions

Placebo DRUG

capsules, daily, orally

Placebo

Vortioxetine (Lu AA21004) DRUG

encapsulated tablets, daily, orally

Also known as: Brintellix

Vortioxetine: 5 or 10 mg

Eligibility Criteria

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

You may qualify if:

• Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
• At least one other MDE before the current one
• Moderate to severe depression

You may not qualify if:

• Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR
• Any substance disorder within the previous 6 months
• Female patients of childbearing potential who are not using effective contraception
• Use of any psychoactive medication 2 weeks prior to screening and during the study
• Randomisation Criteria: Patients in remission (MADRS total score \<=10) at both Week 10 and Week 12

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Related Publications (3)

• Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012 Nov;26(11):1408-16. doi: 10.1177/0269881112441866. Epub 2012 Apr 9.

  PMID: 22495621 RESULT

• Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.

  PMID: 31818787 DERIVED

• McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.

  PMID: 27780334 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 31, 2014
• Results First Posted: March 31, 2014

Record last verified: 2014-02