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

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Treatment Outcome

Intervention: Vortioxetine (Drug); Escitalopram (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Senior Medical Director, Study Director, Affiliation: Takeda

Summary

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

Clinical Details

Official title: A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Flexible-Dose Study Evaluating the Effect of Lu AA21004 vs Escitalopram on Sexual Functioning in Adults With Well-Treated Major Depressive Disorder Experiencing Selective Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8

Secondary outcome:

Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed

Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Birmingham, Alabama, United States

Medicine Hat, Alberta, Canada

Tucson, Arizona, United States

Kelowna, British Columbia, Canada

Penticton, British Columbia, Canada

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, 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

Sydney, Nova Scotia, Canada

Cincinatti, Ohio, United States

Dayton, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Burlington, Ontario, Canada

Chatham, Ontario, Canada

Kingston, Ontario, Canada

Mississauga, Ontario, Canada

Toronto, Ontario, Canada

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

Additional Information

Starting date: June 2011
Last updated: October 6, 2014

Page last updated: August 23, 2015

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