Effect of Lu AA21004 Versus Escitalopram on Sexual Functioning in Adults With Well-Treated Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01364649
First received: May 31, 2011
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Treatment Outcome
Drug: Lu AA21004
Drug: Escitalopram
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change from Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score (Week 8). [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.


Secondary Outcome Measures:
  • Change from Baseline in the CSFQ-14 total score (Week 1). [ Time Frame: Baseline and Week 1. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.

  • Change from Baseline in the CSFQ-14 total score (Week 2). [ Time Frame: Baseline and Week 2. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.

  • Change from Baseline in the CSFQ-14 total score (Week 4). [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.

  • Change from Baseline in the CSFQ-14 total score (Week 6). [ Time Frame: Baseline and Week 6. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.

  • Number of participants with a shift in the CSFQ-14 from abnormal (defined as a CSFQ-14 total score ≤41 for women and ≤47 for men) at Baseline, to normal (defined as >41 for women and >47 for men) (Week 1). [ Time Frame: Baseline and Week 1. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.

  • Number of participants with a shift in the CSFQ-14 from abnormal (defined as a CSFQ-14 total score ≤41 for women and ≤47 for men) at Baseline, to normal (defined as >41 for women and >47 for men) (Week 2). [ Time Frame: Baseline and Week 2. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.

  • Number of participants with a shift in the CSFQ-14 from abnormal (defined as a CSFQ-14 total score ≤41 for women and ≤47 for men) at Baseline, to normal (defi ned as >41 for women and >47 for men) (Week 4). [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.

  • Number of participants with a shift in the CSFQ-14 from abnormal (defined as a CSFQ-14 total score ≤41 for women and ≤47 for men) at Baseline, to normal (defined as >41 for women and >47 for men) (Week 6). [ Time Frame: Baseline and Week 6. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.

  • Number of participants with a shift in the CSFQ-14 from abnormal (defined as a CSFQ-14 total score ≤41 for women and ≤47 for men) at Baseline, to normal (defined as >4 for women and >47 for men) (Week 8). [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]
    The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Lower scores are associated with worsened sexual functioning.


Enrollment: 447
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA21004 QD Drug: Lu AA21004

Lu AA21004 10 mg, capsules, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.

At week 8, Lu AA21004 placebo-matching capsules, orally, once daily for 1 week only.

Active Comparator: Escitalopram QD Drug: Escitalopram

Escitalopram 10 mg, capsules, 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.

Other Name: Lexapro

Detailed Description:

Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder (MDD) is among the most important causes of disability worldwide, in both developing and developed countries.

Lu AA21004 is under codevelopment by Takeda Global Research & Development Center, Inc. and H. Lundbeck A/S for the treatment of MDD and general anxiety disorder (GAD).

Treatment with antidepressants, including selective serotonin reuptake inhibitors (SSRIs), may be associated with sexual dysfunction, which can result in poor treatment compliance or antidepressant treatment discontinuation.

The objective of this study is to further investigate effects of Lu AA21004 in sexual functioning compared with an SSRI, escitalopram, over 8 weeks of treatment by using an objective measure, the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14), in adult participants with well treated MDD but are experiencing SSRI-induced sexual dysfunction.

Participants will be seen weekly during the first 2 weeks of treatment and then every 2 weeks up to the end of the 8-week Treatment Period.

Participants who complete the 8-week Treatment Period will enter a 1-week, double-blind, Taper-Down Period.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is a man or a woman aged between 18 and 55 years, inclusive, who is currently being treated with 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. The depression is currently stable; and the subject has a Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score of ≤3.
  3. The participant is currently experiencing treatment-emergent sexual dysfunction (TESD; defined as a 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. The participant has previously participated in a Lu AA21004 clinical study.
  2. The participant 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. 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. Male participant 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. The participant or participant's sexual partner(s) plans to initiate treatment for sexual dysfunction during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364649

  Show 62 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Medical Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01364649     History of Changes
Other Study ID Numbers: LuAA21004_318, U1111-1120-3483
Study First Received: May 31, 2011
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Takeda:
Sexual Dysfunction, Physiological
Depressive Disorder, Major
Depression
Antidepressive Agents
Drug Therapy

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 20, 2014