Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study

NCT01152996 | Completed Phase 3 Results

• 2 other identifiers: LuAA21004_314U1111-1115-4927
• Study Type: interventional
• Target: 1,075
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the long-term safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder.

Conditions

Depressive Disorder, Major

Keywords

Depression; Melancholia; Paraphrenia; Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%

  Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.

  Over the 52 week period

• Number of Participants With Serious Treatment-Emergent Adverse Events

  Serious treatment-emergent adverse events (serious-TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A serious-TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered serious adverse events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.

  Over the 52 week period

• Treatment-Emergent Adverse Events Leading to Study Discontinuation

  Treatment-emergent adverse events are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.

  Over the 52 week period

Secondary Outcomes (7)

• Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

  Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52

• Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score

  Baseline and Weeks 4, 24, and 52

• Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)

  Baseline and Weeks 4, 24, and 52

• Change From Baseline in Sheehan Disability Scale (SDS) Total Score

  Baseline and Weeks 12, 24, 36, and 52

• Change From Baseline in SDS Work/School Subscale

  Baseline and Weeks 12, 24, 36, and 52

Study Arms (1)

Vortioxetine

EXPERIMENTAL

Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

Vortioxetine tablets

Also known as: LuAA21004

Vortioxetine

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has completed either study LuAA21004\_315 ( NCT01153009), LuAA21004\_316 (NCT01163266), or LuAA21004\_317 (NCT01179516) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the Week 8 \[Lu AA21004\_317\] or Week 10 \[Lu AA21004\_315 or Lu AA21004\_316\] assessment of the preceding protocol).
• Suffers from a recurrent major depressive episode) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) at entry into the prior study.
• Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this participant according to the opinion of the investigator.
• Females of childbearing potential who are sexually active with a nonsterilized male partner agree to routinely use adequate contraception throughout the duration of the study.

You may not qualify if:

• Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
• In the investigator's clinical judgment, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS).
• In the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
• Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
• Has used/uses disallowed concomitant medication.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Senior Medical Director

  Takeda

  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: June 28, 2010
• First Posted: June 29, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 28, 2014
• Results First Posted: May 28, 2014

Record last verified: 2014-04