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Trial record 16 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

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

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ClinicalTrials.gov Identifier: NCT01364649
Recruitment Status : Completed
First Posted : June 2, 2011
Results First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Treatment Outcome
Interventions Drug: Vortioxetine
Drug: Escitalopram
Drug: Placebo
Enrollment 447
Recruitment Details Participants took part in the study at 57 sites in the US and 9 sites in Canada from 16 June 12011 to 9 December 2013.
Pre-assignment Details Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 2 (flexible doses of either vortioxetine (Lu AA21004) 10/20 mg once daily (QD) or escitalopram 10/20 mg QD) treatment groups.
Arm/Group Title Vortioxetine Escitalopram
Hide Arm/Group Description 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. 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
Period Title: Overall Study
Started 225 222
Completed 169 179
Not Completed 56 43
Reason Not Completed
Pretreatment Event or Adverse Event             20             14
Lack of Efficacy             6             0
Non-compliance with Investigational Drug             1             0
Protocol Deviations             4             8
Withdrawal of Consent             9             7
Lost to Follow-up             12             13
Other             4             1
Arm/Group Title Vortioxetine Escitalopram Total
Hide Arm/Group Description 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. 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 Total of all reporting groups
Overall Number of Baseline Participants 225 222 447
Hide Baseline Analysis Population Description
All randomized set (N=447): All study participants who were screened and randomized to one of two treatment arms.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 225 participants 222 participants 447 participants
39.3  (9.96) 40.2  (10.01) 39.8  (9.98)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 222 participants 447 participants
≤41 years 122 112 234
>41 years 103 110 213
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 222 participants 447 participants
Female
128
  56.9%
135
  60.8%
263
  58.8%
Male
97
  43.1%
87
  39.2%
184
  41.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 222 participants 447 participants
Hispanic or Latino 14 36 50
Non-Hispanic and Non-Latino 211 186 397
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 222 participants 447 participants
Caucasian (or White, including Hispanic) 178 181 359
Black of African American 41 35 76
Asian 4 3 7
American Indian or Alaska Native 1 3 4
Native Hawaiian or Other Pacific Islander 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 225 participants 222 participants 447 participants
225 222 447
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 225 participants 222 participants 447 participants
169.6  (9.73) 170.3  (8.81) 169.9  (9.28)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 225 participants 222 participants 447 participants
79.62  (16.202) 81.22  (16.012) 80.41  (16.110)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 225 participants 222 participants 447 participants
27.54  (4.352) 27.90  (4.440) 27.72  (4.395)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 225 participants 222 participants 447 participants
90.85  (13.274) 93.31  (13.074) 92.07  (13.218)
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 222 participants 447 participants
Never smoked 112 126 238
Current smoker 69 55 124
Ex-smoker 44 41 85
Alcohol Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 222 participants 447 participants
Never 65 65 130
Once monthly or less often 86 82 168
Once a week 40 37 77
2 to 6 times per week 33 36 69
Daily 1 2 3
Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 225 participants 222 participants 447 participants
36.5  (5.81) 36.3  (5.62) 36.4  (5.71)
[1]
Measure Description: 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. Higher scores reflect higher sexual functioning. The number of participants with available data were 220 and 216 in each treatment arm respectively.
Montgomery Åsberg Depression Rating Scale (MADRS) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 225 participants 222 participants 447 participants
7.9  (6.28) 8.3  (6.53) 8.1  (6.40)
[1]
Measure Description: The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The number of participants with available data were 224 and 221 in each treatment arm respectively.
Clinical Global Impression - Severity scale (CGI-S) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 225 participants 222 participants 447 participants
2.0  (0.81) 2.0  (0.84) 2.0  (0.82)
[1]
Measure Description: The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. The number of participants with available data were 224 and 221 in each treatment arm respectively.
Profile of Mood States (POMS) Brief Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 225 participants 222 participants 447 participants
18.8  (19.36) 19.7  (19.45) 19.2  (19.39)
[1]
Measure Description: POMS brief is a rating scale, which comprises of 30 items that are evaluated in a 0-4 scale (0=not at all and 4=extremely). The scores for the 30 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score. The number of participants with available data were 224 and 219 in each treatment arm respectively.
1.Primary Outcome
Title Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8
Hide Description 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. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.
Arm/Group Title Vortioxetine Escitalopram
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 165 173
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
8.8  (0.64) 6.6  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vortioxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Mixed Model Repeated Measurements
Comments The primary analysis was performed by using observed case data only.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
0.48 to 4.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.90
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed
Hide Description 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. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.
Time Frame Baseline and Weeks 1, 2, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.
Arm/Group Title Vortioxetine Escitalopram
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 217 207
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=213, 206) 2.5  (0.39) 2.2  (0.40)
Week 2 (n=203, 200) 4.9  (0.46) 3.7  (0.47)
Week 4 (n=187, 188) 7.0  (0.55) 4.8  (0.55)
Week 6 (n=175, 176) 8.0  (0.59) 6.4  (0.60)
3.Secondary Outcome
Title Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed
Hide Description 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. Higher scores reflect higher sexual functioning. Normal sexual functioning is defined as a CSFQ-14 total score of >41 for women and >47 for men. Abnormal sexual functioning is defined as a CSFQ-14 total score of ≤41 for women and ≤47 for men. All subjects entered the study with abnormal sexual functioning. A shift to normal indicates that symptoms have improved.
Time Frame Baseline and Weeks 1, 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. Last observation carried forward.
Arm/Group Title Vortioxetine Escitalopram
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 217 207
Measure Type: Number
Unit of Measure: number of participants
Week 1 (n=213, 205) 48 36
Week 2 (n=217, 206) 81 63
Week 4 (n=217, 206) 93 84
Week 6 (n=217, 206) 112 93
Week 8 (n=217, 206) 113 91
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Up to 12 weeks).
Adverse Event Reporting Description At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who received study drug.
 
Arm/Group Title Vortioxetine Escitalopram
Hide Arm/Group Description 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. 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
All-Cause Mortality
Vortioxetine Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vortioxetine Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   3/224 (1.34%)   1/221 (0.45%) 
Cardiac disorders     
Angina pectoris  1  1/224 (0.45%)  0/221 (0.00%) 
Gastrointestinal disorders     
Mesenteric vein thrombosis  1  0/224 (0.00%)  1/221 (0.45%) 
Psychiatric disorders     
Depression  1  2/224 (0.89%)  0/221 (0.00%) 
Anxiety  1  1/224 (0.45%)  0/221 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/224 (0.45%)  0/221 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vortioxetine Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   90/224 (40.18%)   60/221 (27.15%) 
Gastrointestinal disorders     
Nausea  1  56/224 (25.00%)  12/221 (5.43%) 
General disorders     
Irritability  1  11/224 (4.91%)  16/221 (7.24%) 
Fatigue  1  10/224 (4.46%)  12/221 (5.43%) 
Nervous system disorders     
Headache  1  21/224 (9.38%)  17/221 (7.69%) 
Dizziness  1  18/224 (8.04%)  11/221 (4.98%) 
Psychiatric disorders     
Anxiety  1  4/224 (1.79%)  12/221 (5.43%) 
Skin and subcutaneous tissue disorders     
Pruritus generalised  1  13/224 (5.80%)  0/221 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01364649     History of Changes
Other Study ID Numbers: LuAA21004_318
U1111-1120-3483 ( Registry Identifier: WHO )
First Submitted: May 31, 2011
First Posted: June 2, 2011
Results First Submitted: October 6, 2014
Results First Posted: October 9, 2014
Last Update Posted: October 9, 2014