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Trial record 81 of 89 for:    DESVENLAFAXINE

Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01838876
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Cariprazine
Drug: Antidepressant Therapy (ADT)
Enrollment 442
Recruitment Details  
Pre-assignment Details Rollover participants from Study RGH-MD-72 [NCT01715805] were eligible for this study if they had completed either the double-blind treatment or the continued-treatment periods. New patients were eligible if they had an ongoing inadequate response to a protocol-allowed antidepressant therapy (ADT).
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description Cariprazine, flexible dose (titrated to a dose of 3.0milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Period Title: Overall Study
Started 442
Safety Population; Received Study Drug 345
Entered Safety Follow-up Period 287
Completed 209
Not Completed 233
Reason Not Completed
Adverse Event             49
Insufficient Therapeutic Response             10
Protocol Violation             34
Withdrawal of Consent             33
Lost to Follow-up             21
Study or Site Terminated by Sponsor             1
Reason not Specified             7
Did not meet eligibility criteria             78
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Baseline Participants 345
Hide Baseline Analysis Population Description
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 345 participants
46.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants
Female
249
  72.2%
Male
96
  27.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 345 participants
White
280
  81.2%
Black or African American
54
  15.7%
Asian
6
   1.7%
American Indian or Alaska Native
1
   0.3%
Native Hawaiian or Other Pacific Islander
1
   0.3%
Other
3
   0.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 345 participants
Hispanic or Latino
75
  21.7%
Non-Hispanic or Latino
270
  78.3%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
Hide Description An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.
Time Frame First dose of study drug to last dose of study drug in the 26-week Treatment Period and within 30 days of last dose of study drug for participants who did not participate in the 2-week Safety Follow-up Period (Up to 30 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Participants Analyzed 345
Measure Type: Count of Participants
Unit of Measure: Participants
274
  79.4%
2.Primary Outcome
Title Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period
Hide Description An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the 2-week Safety Follow-up Period.
Time Frame 2 weeks following the 26-week Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population, all participants in the enrolled population who took at least 1 dose of cariprazine in this study, who entered the Safety Follow-up period.
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Participants Analyzed 287
Measure Type: Count of Participants
Unit of Measure: Participants
20
   7.0%
3.Primary Outcome
Title Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Hide Description Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.
Time Frame Baseline (Week 0) to up to 26 weeks in the Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Participants Analyzed 345
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Primary Outcome
Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Hide Description Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.
Time Frame Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Participants Analyzed 345
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Primary Outcome
Title Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
Hide Description A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.
Time Frame Baseline (Week 0) to up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Participants Analyzed 345
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.3%
6.Primary Outcome
Title Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs
Hide Description Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.
Time Frame First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Participants Analyzed 345
Measure Type: Count of Participants
Unit of Measure: Participants
98
  28.4%
7.Primary Outcome
Title Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period
Hide Description The Columbia–Suicide Severity Rating Scale (C-SSRS) is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). The C-SSRS also captures information about the intensity of ideation, specifically the frequency, duration, controllability, deterrents, and reasons for the most severe types of ideation. Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior to 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes.
Time Frame Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: participants
No Suicidal Ideation 308
Suicidal Ideation 37
Suicidal Ideation with Specific Plan and Intent 1
Ideation,Some Intent to Act,without Specific Plan 0
Ideation,any Methods,without Intent to Act 6
Non-specific Active Suicidal Thoughts 3
Wish to be Dead 27
No Suicidal Behavior 344
Suicidal Behavior 1
Completed Suicide 0
Actual Suicide Attempt 1
8.Primary Outcome
Title Number of Participants With Treatment-Emergent Ocular Events
Hide Description A TEAE is an AE that occurs or worsens after receiving study drug. Ocular events are adverse events related to the eye.
Time Frame First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Overall Number of Participants Analyzed 345
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.3%
9.Primary Outcome
Title Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score
Hide Description The ASEX is a participant-completed scale to evaluate overall sexual experiences over the previous 7 days consisting of 5 questions answered on a scale of 1 (best) to 6 (worst) for a total possible score of 3 to 30 (2 questions were only answered if the participant was sexually active in the past week), higher score indicates greater sexual dysfunction. There are different forms for males and females. A negative change from Baseline indicates improvement.
Time Frame Baseline (Lead-in study Baseline for roll-over participants and prior to first dose of this study for new participants) to End of Treatment (Up to Week 26) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Population, all participants in the enrolled population who took at least 1 dose of cariprazine in this study, with data available for analysis at the given time-point.
Arm/Group Title Cariprazine + ADT (Female) Cariprazine + ADT (Male)
Hide Arm/Group Description:
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigators judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks for female participants.
Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigators judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks for male participants.
Overall Number of Participants Analyzed 229 88
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 20.1  (5.9) 17.2  (5.5)
Change from Baseline to the End of Treatment -0.9  (4.4) -0.1  (4.6)
Time Frame First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cariprazine + ADT
Hide Arm/Group Description Cariprazine, flexible dose (titrated to a dose of 3.0 mg adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
All-Cause Mortality
Cariprazine + ADT
Affected / at Risk (%)
Total   2/345 (0.58%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cariprazine + ADT
Affected / at Risk (%)
Total   7/345 (2.03%) 
Infections and infestations   
Pneumonia  1  1/345 (0.29%) 
Injury, poisoning and procedural complications   
Fall  1  1/345 (0.29%) 
Road traffic accident  1  1/345 (0.29%) 
Spinal cord injury  1  1/345 (0.29%) 
Investigations   
Blood creatine phosphokinase increased  1  1/345 (0.29%) 
Psychiatric disorders   
Completed suicide  1  1/345 (0.29%) 
Substance-induced psychotic disorder  1  1/345 (0.29%) 
Suicide attempt  1  1/345 (0.29%) 
1
Term from vocabulary, MedDRA 18.0
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%
Cariprazine + ADT
Affected / at Risk (%)
Total   274/345 (79.42%) 
Gastrointestinal disorders   
Nausea  1  21/345 (6.09%) 
General disorders   
Fatigue  1  30/345 (8.70%) 
Infections and infestations   
Nasopharyngitis  1  30/345 (8.70%) 
Investigations   
Weight increased  1  34/345 (9.86%) 
Nervous system disorders   
Akathisia  1  55/345 (15.94%) 
Headache  1  40/345 (11.59%) 
Dizziness  1  20/345 (5.80%) 
Sedation  1  19/345 (5.51%) 
Psychiatric disorders   
Anxiety  1  34/345 (9.86%) 
Insomnia  1  34/345 (9.86%) 
Restlessness  1  34/345 (9.86%) 
1
Term from vocabulary, MedDRA 18.0
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01838876     History of Changes
Other Study ID Numbers: RGH-MD-76
First Submitted: April 22, 2013
First Posted: April 24, 2013
Results First Submitted: July 29, 2019
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019