ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 959 for:    Score | "Depressive Disorder, Major"

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in 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: NCT01469377
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Placebo
Drug: Cariprazine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Cariprazine 1-2 mg Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Cariprazine 2-4.5 mg Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Participant Flow:   Overall Study
    Placebo   Cariprazine 1-2 mg   Cariprazine 2-4.5 mg
STARTED   269   274   276 
COMPLETED   234   226   210 
NOT COMPLETED   35   48   66 
Protocol Deviation                7                10                10 
Lost to Follow-up                3                2                5 
Withdrawal of Consent                12                14                15 
Adverse Event                8                18                36 
Insufficient Therapeutic Response                3                4                0 
Other Miscellaneous Reasons                2                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety Population consisted of all subjects in the Randomized Population who received at least 1 dose of double-blind investigational product.

Reporting Groups
  Description
Placebo Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Cariprazine 1-2 mg Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Cariprazine 2-4.5 mg Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.
Total Total of all reporting groups

Baseline Measures
   Placebo   Cariprazine 1-2 mg   Cariprazine 2-4.5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 266   273   273   812 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.4  (11.6)   45.5  (11.9)   45.1  (11.4)   45.7  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      190  71.4%      187  68.5%      201  73.6%      578  71.2% 
Male      76  28.6%      86  31.5%      72  26.4%      234  28.8% 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   230   234   242   706 
All other races   36   39   31   106 
Black or African American   32   31   24   87 
Asian   1   4   4   9 
American Indian or Alaska Native   2   1   1   4 
Other   1   3   2   6 
Race/Ethnicity, Customized 
[Units: Participants]
       
Hispanic or Latino   14   17   22   53 
Not Hispanic or Latino   252   256   251   759 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 81.53  (16.19)   79.69  (16.31)   82.17  (17.37)   81.13  (16.65) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28.93  (5.09)   28.21  (5.51)   29.05  (5.59)   28.73  (5.41) 
Waist Circumference 
[Units: Cm]
Mean (Standard Deviation)
 94.32  (13.44)   93.36  (14.20)   94.91  (14.66)   94.20  (14.12) 


  Outcome Measures

1.  Primary:   Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8   [ Time Frame: Baseline to Week 8 ]

2.  Secondary:   Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8   [ Time Frame: Baseline to Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Allergan
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01469377     History of Changes
Other Study ID Numbers: RGH-MD-75
First Submitted: November 8, 2011
First Posted: November 10, 2011
Results First Submitted: March 29, 2018
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018