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Trial record 98 of 482 for:    ESCITALOPRAM AND Antagonists

Escitalopram in Adult Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00668525
Recruitment Status : Completed
First Posted : April 29, 2008
Results First Posted : May 6, 2010
Last Update Posted : May 11, 2010
Sponsor:
Information provided by:
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Escitalopram
Drug: Placebo
Enrollment 877
Recruitment Details Recruitment period was from 4/30/08 through 12/19/08 with last patient last visit on 2/24/09 at 45 centers in the US.
Pre-assignment Details A one-week single-blind placebo period was completed prior to randomization. Patients were then randomized in a 3:3:2 ratio to either escitalopram low dose, escitalopram high dose or placebo.
Arm/Group Title Escitalopram Low Dose Escitalopram High Dose Placebo
Hide Arm/Group Description Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population. Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population. Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Period Title: Overall Study
Started 325 [1] 332 [1] 220 [1]
Completed 248 [2] 239 [2] 167 [2]
Not Completed 77 93 53
[1]
The number of patients started are based on the Randomized Population.
[2]
The number of patients completed are based on the Randomized Population.
Arm/Group Title Escitalopram Low Dose Escitalopram High Dose Placebo Total
Hide Arm/Group Description Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population. Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population. Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population. Total of all reporting groups
Overall Number of Baseline Participants 322 324 218 864
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 324 participants 218 participants 864 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
322
 100.0%
324
 100.0%
218
 100.0%
864
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 322 participants 324 participants 218 participants 864 participants
41.4  (12.3) 40.4  (11.9) 42.3  (12.7) 41.3  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 324 participants 218 participants 864 participants
Female
205
  63.7%
222
  68.5%
137
  62.8%
564
  65.3%
Male
117
  36.3%
102
  31.5%
81
  37.2%
300
  34.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 322 participants 324 participants 218 participants 864 participants
322 324 218 864
1.Primary Outcome
Title Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
Hide Description The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).
Time Frame Change from baseline in MADRS total score at week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline MADRS total score as a covariate.
Arm/Group Title Escitalopram Low Dose Escitalopram High Dose Placebo
Hide Arm/Group Description:
Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Overall Number of Participants Analyzed 319 318 215
Mean (Standard Error)
Unit of Measure: Units on a scale
-12.8  (0.6) -13.4  (0.6) -10.1  (0.7)
2.Secondary Outcome
Title Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8
Hide Description The HAMD is a clinician-rated 24-item scale was used to rate the patient’s depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).
Time Frame Change from baseline in HAM-D at week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline HAMD total score as a covariate.
Arm/Group Title Escitalopram Low Dose Escitalopram High Dose Placebo
Hide Arm/Group Description:
Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Overall Number of Participants Analyzed 319 318 215
Mean (Standard Error)
Unit of Measure: Units on a scale
-11.5  (0.5) -11.6  (0.6) -8.5  (0.6)
Time Frame 10 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Low Dose Escitalopram High Dose Placebo
Hide Arm/Group Description Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population. Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population. Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
All-Cause Mortality
Escitalopram Low Dose Escitalopram High Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Low Dose Escitalopram High Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/322 (0.93%)      7/324 (2.16%)      4/218 (1.83%)    
General disorders       
Chest Pain  1  1/322 (0.31%)  1 1/324 (0.31%)  1 0/218 (0.00%)  0
Infections and infestations       
Appendicitis  1  0/322 (0.00%)  0 1/324 (0.31%)  1 0/218 (0.00%)  0
Pharyngitis  1  1/322 (0.31%)  1 0/324 (0.00%)  0 0/218 (0.00%)  0
Injury, poisoning and procedural complications       
Injury  1  0/322 (0.00%)  0 0/324 (0.00%)  0 1/218 (0.46%)  1
Nervous system disorders       
Multiple Sclerosis  1  1/322 (0.31%)  1 0/324 (0.00%)  0 0/218 (0.00%)  0
Psychiatric disorders       
Anxiety  1  0/322 (0.00%)  0 2/324 (0.62%)  2 0/218 (0.00%)  0
Suicidal ideation  1  0/322 (0.00%)  0 1/324 (0.31%)  1 1/218 (0.46%)  1
Suicide Attempt * 1  0/322 (0.00%)  0 1/324 (0.31%)  1 0/218 (0.00%)  0
Depression  1  0/322 (0.00%)  0 0/324 (0.00%)  0 2/218 (0.92%)  2
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/322 (0.00%)  0 0/324 (0.00%)  0 1/218 (0.46%)  1
Haemothorax  1  0/322 (0.00%)  0 0/324 (0.00%)  0 1/218 (0.46%)  1
Vascular disorders       
Peripheral vascular disorder  1  0/322 (0.00%)  0 1/324 (0.31%)  1 0/218 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Low Dose Escitalopram High Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   146/322 (45.34%)      160/324 (49.38%)      74/218 (33.94%)    
Gastrointestinal disorders       
Nausea  1  41/322 (12.73%)  37/324 (11.42%)  16/218 (7.34%) 
Diarrhea  1  30/322 (9.32%)  35/324 (10.80%)  14/218 (6.42%) 
Dry mouth  1  23/322 (7.14%)  28/324 (8.64%)  7/218 (3.21%) 
General disorders       
Fatigue  1  18/322 (5.59%)  20/324 (6.17%)  4/218 (1.83%) 
Infections and infestations       
Nasopharyngitis  1  6/322 (1.86%)  12/324 (3.70%)  11/218 (5.05%) 
Nervous system disorders       
Headache  1  52/322 (16.15%)  45/324 (13.89%)  31/218 (14.22%) 
Somnolence  1  17/322 (5.28%)  26/324 (8.02%)  4/218 (1.83%) 
Dizziness  1  15/322 (4.66%)  14/324 (4.32%)  12/218 (5.50%) 
Psychiatric disorders       
Insomnia  1  19/322 (5.90%)  34/324 (10.49%)  7/218 (3.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
Sponsor can review results communications prior to public release & can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor’s confidential info. Upon sponsor’s request, PI shall delete any proprietary info & shall not include raw data in pub. On sponsor’s request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.
Results Point of Contact
Name/Title: Carl Gommoll, MS
Organization: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Phone: 201-427-8000
Responsible Party: Carl Gommoll, Study Director, Forest Laboratories
ClinicalTrials.gov Identifier: NCT00668525     History of Changes
Other Study ID Numbers: SCT-MD-49
First Submitted: April 28, 2008
First Posted: April 29, 2008
Results First Submitted: March 22, 2010
Results First Posted: May 6, 2010
Last Update Posted: May 11, 2010