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Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression (RAPID KOR)

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ClinicalTrials.gov Identifier: NCT01913535
Recruitment Status : Terminated (slow enrollment)
First Posted : August 1, 2013
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Butler Hospital
Rush University
Temple University
University of Kansas
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Treatment Resistant Depression
Interventions: Drug: CERC-501
Drug: Placebo

  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
Only 8 participants were randomized because the study terminated early due to slow enrollment.

Reporting Groups
  Description
Low Dose Drug-Drug Arm

Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)

CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).

High Dose Drug-Drug Arm

Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)

CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).

Placebo/Low-Dose Drug Arm

Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)

CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).

For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.

Placebo/High-Dose Drug Arm

Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)

CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).

Placebo/Placebo Arm

Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)

Placebo: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).


Participant Flow for 2 periods

Period 1:   Phase 1 (Days 0-2)
    Low Dose Drug-Drug Arm   High Dose Drug-Drug Arm   Placebo/Low-Dose Drug Arm   Placebo/High-Dose Drug Arm   Placebo/Placebo Arm
STARTED   2   2   1   2   1 
COMPLETED   2   2   1   2   1 
NOT COMPLETED   0   0   0   0   0 

Period 2:   Phase 2 (Days 3-5)
    Low Dose Drug-Drug Arm   High Dose Drug-Drug Arm   Placebo/Low-Dose Drug Arm   Placebo/High-Dose Drug Arm   Placebo/Placebo Arm
STARTED   2   2   1   2   1 
COMPLETED   2   2   1   2   1 
NOT COMPLETED   0   0   0   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.
Only 8 participants were randomized because the study terminated early due to slow enrollment.

Reporting Groups
  Description
Low Dose Drug-Drug Arm

Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)

CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).

High Dose Drug-Drug Arm

Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)

CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).

Placebo/Low-Dose Drug Arm

Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)

CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).

Placebo/High-Dose Drug Arm

Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)

CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).

Placebo/Placebo Arm Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
Total Total of all reporting groups

Baseline Measures
   Low Dose Drug-Drug Arm   High Dose Drug-Drug Arm   Placebo/Low-Dose Drug Arm   Placebo/High-Dose Drug Arm   Placebo/Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   1   2   1   8 
Age 
[Units: Years]
Median (Full Range)
 58.2 
 (52.1 to 64.4) 
 58.3 
 (58.0 to 58.5) 
 34.5 
 (34.5 to 34.5) 
 36.3 
 (27.2 to 45.4) 
 38.8 
 (38.8 to 38.8) 
 48.8 
 (27.2 to 64.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      2 100.0%      2 100.0%      1 100.0%      2 100.0%      1 100.0%      8 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      2 100.0%      2 100.0%      1 100.0%      2 100.0%      1 100.0%      8 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      2 100.0%      2 100.0%      1 100.0%      2 100.0%      1 100.0%      8 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
           
United States   2   2   1   2   1   8 


  Outcome Measures

1.  Primary:   Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)   [ Time Frame: Baseline and 72 hours after initiating treatment ]

2.  Secondary:   Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6), Day 20   [ Time Frame: Baseline and 20 days after initiating treatment ]

3.  Secondary:   Number of Participants With Response on Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)   [ Time Frame: 72 hours after treatment initiation ]

4.  Secondary:   Change in Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: Baseline and 72 hours and 20 days after initiating treatment ]

5.  Secondary:   Change in Clinical Global Impression -Severity (CGI-S)   [ Time Frame: Baseline and 72 hours and 20 days after initiating treatment ]

6.  Secondary:   Clinical Global Impression-Improvement (CGI-I)   [ Time Frame: 72 hours and 20 days after initiating treatment ]

7.  Secondary:   Change in Symptoms of Depression Questionnaire (SDQ)   [ Time Frame: Baseline and 72 hours and 20 days after initiating treatment ]

8.  Secondary:   Change in Perceived Stress Scale (PSS)   [ Time Frame: Baseline and 72 hours and 20 days after treatment initiation ]

9.  Secondary:   Change in Positive Affect Scale (PAS)   [ Time Frame: Baseline and 72 hours and 20 days after initiating treatment ]

10.  Secondary:   Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities   [ Time Frame: Baseline and 72 hours and 20 days after initiating treatment ]

11.  Secondary:   Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Baseline and 72 hours after initiating treatment ]

12.  Secondary:   Number of Participants With Clinically Significant Abnormal ECG   [ Time Frame: 72 hours after treatment initiation ]

13.  Secondary:   Number of Participants With Clinically Significant Abnormal Labs   [ Time Frame: 72 hours after treatment initiation ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Maurizio Fava, MD
Organization: Massachusetts General Hospital
phone: 617-724-2513
e-mail: mfava@mgh.harvard.edu



Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01913535     History of Changes
Other Study ID Numbers: RAP-002
271201100006I-0-27100007-1 ( U.S. NIH Grant/Contract )
First Submitted: July 30, 2013
First Posted: August 1, 2013
Results First Submitted: April 17, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017