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Trial record 35 of 1892 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder

Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00854100
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Antidepressant + placebo
Drug: Antidepressant + cariprazine (0.1-0.3 mg/day)
Drug: Antidepressant + cariprazine (1-2 mg/d)
Enrollment 231
Recruitment Details  
Pre-assignment Details The randomized population for RGH-MD-71 totaled 231 participants
Arm/Group Title Placebo Cariprazine 0.1 – 0.3 mg Cariprazine 1.0 – 2.0 mg
Hide Arm/Group Description Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
Period Title: Overall Study
Started 81 76 74
Completed 72 70 63
Not Completed 9 6 11
Reason Not Completed
Inability to complete the study visits             0             0             1
Lost to Follow-up             2             0             3
Withdrawal by Subject             3             1             2
Protocol Violation             2             4             3
Adverse Event             2             1             2
Arm/Group Title Placebo Cariprazine 0.1 – 0.3 mg Cariprazine 1.0 – 2.0 mg Total
Hide Arm/Group Description Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose Total of all reporting groups
Overall Number of Baseline Participants 81 76 73 230
Hide Baseline Analysis Population Description
A total of 231 patients were eligible for randomization to double-blind treatment; 230 patients were randomized and received at least 1 dose of treatment (Double-blind Safety Population)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 76 participants 73 participants 230 participants
45.2  (10.2) 46.6  (11.7) 44.2  (12.1) 45.3  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 76 participants 73 participants 230 participants
Female
61
  75.3%
52
  68.4%
51
  69.9%
164
  71.3%
Male
20
  24.7%
24
  31.6%
22
  30.1%
66
  28.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 76 participants 73 participants 230 participants
Hispanic or Latino
7
   8.6%
9
  11.8%
9
  12.3%
25
  10.9%
Not Hispanic or Latino
74
  91.4%
67
  88.2%
64
  87.7%
205
  89.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 76 participants 73 participants 230 participants
American Indian or Alaska Native
2
   2.5%
0
   0.0%
0
   0.0%
2
   0.9%
Asian
0
   0.0%
2
   2.6%
1
   1.4%
3
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  12.3%
15
  19.7%
11
  15.1%
36
  15.7%
White
69
  85.2%
57
  75.0%
60
  82.2%
186
  80.9%
More than one race
0
   0.0%
2
   2.6%
1
   1.4%
3
   1.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.
Time Frame Baseline (Week 8) to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses.
Arm/Group Title Placebo Cariprazine 0.1 – 0.3 mg Cariprazine 1.0 – 2.0 mg
Hide Arm/Group Description:
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
Overall Number of Participants Analyzed 81 76 73
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-8.0  (1.0) -7.5  (1.1) -9.8  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine 0.1 – 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-2.4 to 3.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine 1.0 – 2.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-4.8 to 1.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinical Global Impression – Improvement (CGI-I)
Hide Description The Clinical Global Impression–Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses.
Arm/Group Title Placebo Cariprazine 0.1 – 0.3 mg Cariprazine 1.0 – 2.0 mg
Hide Arm/Group Description:
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
Overall Number of Participants Analyzed 81 76 73
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
2.5  (0.1) 2.5  (0.1) 2.3  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine 0.1 – 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.918
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.3 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine 1.0 – 2.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.1
Estimation Comments [Not Specified]
Time Frame Up to 20 weeks
Adverse Event Reporting Description Any AE includes the prospective ADT lead-in, double-blind treatment and 30 -day safety follow up will be considered a treatment-emergent adverse event (TEAE). A TEAE that occurs more than 30 days after the last dose of the investigational product will not be summarized for the safety follow-up period.1 patient left the study after they were randomized to the Cariprazine 1.0-2.0 mg arm, but never took the drug. Therefore, that patient is only captured in the lead in period data.
 
Arm/Group Title Prospective Antidepressant-Therapy Lead In Period Placebo Cariprazine 0.1 – 0.3 mg Cariprazine 1.0 – 2.0 mg
Hide Arm/Group Description Interventions included: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) for 8 weeks prior to randomization Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it. Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it. Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it.
All-Cause Mortality
Prospective Antidepressant-Therapy Lead In Period Placebo Cariprazine 0.1 – 0.3 mg Cariprazine 1.0 – 2.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/502 (0.20%)   0/81 (0.00%)   0/76 (0.00%)   0/73 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Prospective Antidepressant-Therapy Lead In Period Placebo Cariprazine 0.1 – 0.3 mg Cariprazine 1.0 – 2.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/502 (1.79%)   1/81 (1.23%)   0/76 (0.00%)   1/73 (1.37%) 
Cardiac disorders         
Angina Unstable  1  0/502 (0.00%)  1/81 (1.23%)  0/76 (0.00%)  0/73 (0.00%) 
Injury, poisoning and procedural complications         
Hip Fracture  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Road Traffic Accident  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Upper Limb Fracture  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Intentional Overdose  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Nervous system disorders         
Convulsion  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Serotonin Syndrome  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Psychiatric disorders         
Anxiety  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Suicidal Ideation  1  2/502 (0.40%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Depression  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Completed Suicide  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Alcohol Abuse  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Homicidal Ideation  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Suicide Attempt  1  1/502 (0.20%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic Obstructive Pulmanary Disease  1  0/502 (0.00%)  0/81 (0.00%)  0/76 (0.00%)  1/73 (1.37%) 
1
Term from vocabulary, MedDRA 13.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prospective Antidepressant-Therapy Lead In Period Placebo Cariprazine 0.1 – 0.3 mg Cariprazine 1.0 – 2.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   262/502 (52.19%)   32/81 (39.51%)   29/76 (38.16%)   35/73 (47.95%) 
Gastrointestinal disorders         
Nausea  1  70/502 (13.94%)  5/81 (6.17%)  5/76 (6.58%)  5/73 (6.85%) 
Dry Mouth  1  53/502 (10.56%)  1/81 (1.23%)  2/76 (2.63%)  4/73 (5.48%) 
Constipation  1  35/502 (6.97%)  1/81 (1.23%)  1/76 (1.32%)  4/73 (5.48%) 
Diarrhoea  1  36/502 (7.17%)  5/81 (6.17%)  4/76 (5.26%)  3/73 (4.11%) 
General disorders         
Fatigue  1  36/502 (7.17%)  3/81 (3.70%)  2/76 (2.63%)  5/73 (6.85%) 
Infections and infestations         
Nasopharyngitis  1  0/502 (0.00%)  5/81 (6.17%)  1/76 (1.32%)  6/73 (8.22%) 
Upper Respiratory Tract Infection  1  29/502 (5.78%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
Metabolism and nutrition disorders         
Increased appetite  1  0/502 (0.00%)  1/81 (1.23%)  1/76 (1.32%)  5/73 (6.85%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/502 (0.00%)  1/81 (1.23%)  4/76 (5.26%)  1/73 (1.37%) 
Nervous system disorders         
Headache  1  73/502 (14.54%)  3/81 (3.70%)  8/76 (10.53%)  6/73 (8.22%) 
Dizziness  1  31/502 (6.18%)  7/81 (8.64%)  4/76 (5.26%)  6/73 (8.22%) 
Akathisia  1  0/502 (0.00%)  3/81 (3.70%)  2/76 (2.63%)  4/73 (5.48%) 
Tremor  1  0/502 (0.00%)  4/81 (4.94%)  0/76 (0.00%)  4/73 (5.48%) 
Psychiatric disorders         
Insomnia  1  60/502 (11.95%)  3/81 (3.70%)  2/76 (2.63%)  7/73 (9.59%) 
Anxiety  1  0/502 (0.00%)  3/81 (3.70%)  1/76 (1.32%)  4/73 (5.48%) 
Restlessness  1  0/502 (0.00%)  1/81 (1.23%)  1/76 (1.32%)  7/73 (9.59%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  25/502 (4.98%)  0/81 (0.00%)  0/76 (0.00%)  0/73 (0.00%) 
1
Term from vocabulary, MedDRA 13.0
Indicates events were collected by systematic assessment
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.
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc
Phone: 877-277-8566
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00854100     History of Changes
Obsolete Identifiers: NCT03605784
Other Study ID Numbers: RGH-MD-71
First Submitted: February 26, 2009
First Posted: March 2, 2009
Results First Submitted: July 30, 2018
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019