Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction

NCT ID: NCT01364649

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning.

Detailed Description

The drug being tested in this study is called Lu AA21004. Lu AA21004 is being tested to treat people who have major depressive disorder (MDD). This study will look at sexual function in people who take Lu AA21004.

The study will enroll approximately 440 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• Lu AA21004 10 to 20 mg
• Escitalopram 10 to 20 mg - This is a comparator drug that is also used to treat MDD.

All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to answer questionnaires at each study visit.

This multi-centre trial will be conducted in the United States and Canada. The overall time to participate in this study is 14 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 21 days after last dose of study drug for a follow-up assessment.

Conditions

Treatment Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vortioxetine

Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg, tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Vortioxetine tablets

Placebo

Intervention Type: DRUG

Vortioxetine Placebo-matching capsules

Escitalopram

Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only.

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

Escitalopram tablets

Interventions

Vortioxetine

Vortioxetine tablets

Intervention Type: DRUG

Escitalopram

Escitalopram tablets

Intervention Type: DRUG

Placebo

Vortioxetine Placebo-matching capsules

Intervention Type: DRUG

Other Intervention Names

Lu AA21004; Lexapro

Eligibility Criteria

Inclusion Criteria

1. Is a man or a woman aged between 18 and 55 years, inclusive, who is currently being treated with selective serotonin reuptake inhibitor (SSRI) monotherapy (only citalopram, paroxetine, or sertraline allowed) for at least 8 weeks, which was prescribed to treat a major depressive episode (MDE), according to the DSM-IV-TR criteria.

2. Is currently stable; and has a Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score of ≤3.

3. Is currently experiencing treatment-emergent sexual dysfunction (TESD; defined as a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score ≤41 for women and ≤47 for men), considered to be attributable to the current SSRI monotherapy and is suitable for a switch.

Exclusion Criteria

1. Has previously participated in a Lu AA21004 clinical study.

2. Has 1 or more the following: any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; as assessed by the Mini International Neuropsychiatric Interview Version 6.0.0); current or history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR; current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to Screening (subject must also have negative urine drug screen prior to Baseline); presence or history of a clinically significant neurological disorder (including epilepsy); neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc); or any Axis II disorder that might compromise the study.

3. Has sexual dysfunction associated with an etiology other than SSRI treatment or current MDE (e.g., due to a medical condition, such as diabetes or hypertension, a medication, a genital anatomical deformity, or alcohol abuse).

4. Is nonsexually active or anticipates decreasing frequency of sexual activity (ie, sexual activity anticipated to lead to orgasm or that would normally lead to orgasm, which can include sexual intercourse, oral sex, masturbation, sexual fantasies, and/or thinking of sexual activity) during the course of the study below the level at study initiation.

5. Is a male with a history of premature ejaculation in the past year.

6. Has had major relationship changes during the preceding SSRI treatment period or plans to have major relationship changes during the course of the study.

7. Has a sexual partner(s) who plans to initiate treatment for sexual dysfunction during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Birmingham, Alabama, United States

Tucson, Arizona, United States

Anaheim, California, United States

Chino, California, United States

Costa Mesa, California, United States

Encino, California, United States

Escondido, California, United States

Irvine, California, United States

Newport Beach, California, United States

Oceanside, California, United States

San Diego, California, United States

Norwich, Connecticut, United States

Washington D.C., District of Columbia, United States

Coral Springs, Florida, United States

Fort Myers, Florida, United States

Gainesville, Florida, United States

Jacksonville, Florida, United States

Lauderhill, Florida, United States

North Miami, Florida, United States

Orlando, Florida, United States

Sanford, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Joliet, Illinois, United States

Lake Charles, Louisiana, United States

Shreveport, Louisiana, United States

Gaithersburg, Maryland, United States

Towson, Maryland, United States

Boston, Massachusetts, United States

Weymouth, Massachusetts, United States

Flowood, Mississippi, United States

Creve Coeur, Missouri, United States

St Louis, Missouri, United States

Toms River, New Jersey, United States

Willingboro, New Jersey, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Rochester, New York, United States

Staten Island, New York, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Allentown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

Austin, Texas, United States

Dallas, Texas, United States

Charlottesville, Virginia, United States

Seattle, Washington, United States

Waukesha, Wisconsin, United States

Medicine Hat, Alberta, Canada

Kelowna, British Columbia, Canada

Penticton, British Columbia, Canada

Sydney, Nova Scotia, Canada

Burlington, Ontario, Canada

Chatham, Ontario, Canada

Kingston, Ontario, Canada

Mississauga, Ontario, Canada

Toronto, Ontario, Canada

Countries

United States; Canada

References

Jacobsen PL, Nomikos GG, Zhong W, Cutler AJ, Affinito J, Clayton A. Clinical implications of directly switching antidepressants in well-treated depressed patients with treatment-emergent sexual dysfunction: a comparison between vortioxetine and escitalopram. CNS Spectr. 2020 Feb;25(1):50-63. doi: 10.1017/S1092852919000750.

Reference Type: DERIVED

PMID: 31010445 (View on PubMed)

Other Identifiers

U1111-1120-3483

Identifier Type: REGISTRY

Identifier Source: secondary_id

LuAA21004_318

Identifier Type: -

Identifier Source: org_study_id