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Fast-Fail Trials in Mood and Anxiety Spectrum Disorders; Kappa Opioid Receptor Phase 2a (FASTMAS_Kor2)

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ClinicalTrials.gov Identifier: NCT02218736
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Yale University
Baylor College of Medicine
Indiana University
Icahn School of Medicine at Mount Sinai
Case Western Reserve University
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Interventions Drug: CERC-501
Drug: placebo
Enrollment 163
Recruitment Details  
Pre-assignment Details 69 participants screen failed, 2 were unable to complete baseline per protocol, 3 withdrew consent prior to baseline.
Arm/Group Title CERC-501 Placebo
Hide Arm/Group Description

Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks

CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks

Oral daily administration of 10 mg placebo for 8 weeks

placebo: oral dosing of 10 mg placebo daily for 8 weeks

Period Title: Overall Study
Started 45 44
Completed 33 35
Not Completed 12 9
Reason Not Completed
Withdrawal by Subject             10             9
Protocol Violation             2             0
Arm/Group Title CERC-501 Placebo Total
Hide Arm/Group Description

Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks

CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks

Oral daily administration of 10 mg placebo for 8 weeks

placebo: oral dosing of 10 mg placebo daily for 8 weeks

Total of all reporting groups
Overall Number of Baseline Participants 45 44 89
Hide Baseline Analysis Population Description
Participants who were randomized
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 89 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
 100.0%
44
 100.0%
89
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 44 participants 89 participants
40.7  (13.30) 38.2  (13.02) 39.5  (13.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 89 participants
Female
29
  64.4%
27
  61.4%
56
  62.9%
Male
16
  35.6%
17
  38.6%
33
  37.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 89 participants
Hispanic or Latino
5
  11.1%
5
  11.4%
10
  11.2%
Not Hispanic or Latino
38
  84.4%
38
  86.4%
76
  85.4%
Unknown or Not Reported
2
   4.4%
1
   2.3%
3
   3.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 89 participants
American Indian or Alaska Native
0
   0.0%
1
   2.3%
1
   1.1%
Asian
1
   2.2%
2
   4.5%
3
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  22.2%
8
  18.2%
18
  20.2%
White
31
  68.9%
28
  63.6%
59
  66.3%
More than one race
2
   4.4%
4
   9.1%
6
   6.7%
Unknown or Not Reported
1
   2.2%
1
   2.3%
2
   2.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 45 participants 44 participants 89 participants
45
 100.0%
44
 100.0%
89
 100.0%
1.Primary Outcome
Title Change in Ventral Striatal Activation Occurring in Anticipation of Reward During the Monetary Incentive Delay Task Measured by fMRI
Hide Description Establish POC (Proof of Concept) for KOR (Kappa Opioid Receptor) antagonism by evaluating the impact of CERC-501 relative to Placebo on reward-related neural circuitry in terms of ventral striatal activation during anticipation of reward during the Monetary Incentive Delay Task. Evaluation by fMRI (Functional magnetic resonance imaging). The BOLD (Blood Oxygen Level-Dependent) score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.
Time Frame baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.
Arm/Group Title CERC-501 Placebo
Hide Arm/Group Description:

Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks

CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks

Oral daily administration of 10 mg placebo for 8 weeks

placebo: oral dosing of 10 mg placebo daily for 8 weeks

Overall Number of Participants Analyzed 34 34
Mean (95% Confidence Interval)
Unit of Measure: Z score
0.718
(0.487 to 0.950)
0.331
(0.103 to 0.559)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CERC-501, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0095
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Secondary Outcome
Title Clinical Anhedonia Measured by the Snaith-Hamilton Pleasure Scale (SHAPS; Total Score)
Hide Description To determine if CERC-501 is superior to placebo in improving a clinical self-report measure of anhedonia using the Snaith Hamilton Pleasure Scale (SHAPS). A single value was calculated for the average over 8 weeks. The SHAPS is a well-validated 14-item questionnaire used to assess anhedonia. It asks participants to agree or disagree with statements of hedonic response in pleasurable situations. Four responses are possible: Strongly disagree, Disagree, Agree, or Strongly agree. Each item is worded so that higher scores indicate greater pleasure capacity. A total score is derived by summing the responses to each item. Items answered "strongly agree" are coded as "1", while "strongly disagree" are coded a score of "4." Therefore, scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.
Arm/Group Title CERC-501 Placebo
Hide Arm/Group Description:

Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks

CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks

Oral daily administration of 10 mg placebo for 8 weeks

placebo: oral dosing of 10 mg placebo daily for 8 weeks

Overall Number of Participants Analyzed 34 34
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
30.777
(29.547 to 32.007)
32.363
(31.157 to 33.568)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CERC-501, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0345
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Behavioral Measure of Anhedonia Using the Probabilistic Reward Task
Hide Description To evaluate the impact of CERC-501 relative to placebo on a behavioral measure of anhedonia using the Probabilistic Reward Task (PRT). The PRT will be carried out at baseline and after 8 weeks of double-blind treatment to assess the effects on a behavioral outcome measure that assessed reward-related function (level of reward learning). The score obtained is a ratio of the number of times participants correctly choose the high reward stimuli versus the low rewarding stimuli
Time Frame baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.
Arm/Group Title CERC-501 Placebo
Hide Arm/Group Description:

Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks

CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks

Oral daily administration of 10 mg placebo for 8 weeks

placebo: oral dosing of 10 mg placebo daily for 8 weeks

Overall Number of Participants Analyzed 34 34
Mean (95% Confidence Interval)
Unit of Measure: Ratio (Response Bias Score)
0.034
(-0.019 to 0.087)
0.019
(-0.030 to 0.068)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CERC-501, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.430
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame Adverse events were collected from the time of consent through 12 weeks for all subjects.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CERC-501 Placebo
Hide Arm/Group Description

Oral dosing of 10 mg CERC-501 (formerly known as LY2456302) administered daily for 8 weeks

CERC-501: Oral dosing of 10 mg CERC-501 daily for 8 weeks

Oral daily administration of 10 mg placebo for 8 weeks

placebo: oral dosing of 10 mg placebo daily for 8 weeks

All-Cause Mortality
CERC-501 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/44 (0.00%) 
Hide Serious Adverse Events
CERC-501 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CERC-501 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   34/45 (75.56%)   32/44 (72.73%) 
Blood and lymphatic system disorders     
Neutropenia * 1  0/45 (0.00%)  1/44 (2.27%) 
Cardiac disorders     
Palpitations * 1  0/45 (0.00%)  2/44 (4.55%) 
Chest discomfort * 1  1/45 (2.22%)  0/44 (0.00%) 
Chest pain * 1  1/45 (2.22%)  0/44 (0.00%) 
Ear and labyrinth disorders     
Tinnitus * 1  4/45 (8.89%)  1/44 (2.27%) 
Eye disorders     
Vission Blurred * 1  4/45 (8.89%)  1/44 (2.27%) 
Blepharitis * 1  1/45 (2.22%)  0/44 (0.00%) 
Conjunctivitis * 1  0/45 (0.00%)  1/44 (2.27%) 
Eye pruritus * 1  0/45 (0.00%)  1/44 (2.27%) 
Gastrointestinal disorders     
Diarrhea * 1  13/45 (28.89%)  8/44 (18.18%) 
Dry Mouth * 1  4/45 (8.89%)  4/44 (9.09%) 
Nausea * 1  3/45 (6.67%)  5/44 (11.36%) 
Constipation * 1  4/45 (8.89%)  1/44 (2.27%) 
Abdominal discomfort * 1  0/45 (0.00%)  1/44 (2.27%) 
Anal pruritus * 1  1/45 (2.22%)  0/44 (0.00%) 
Gastrointestinal disorder * 1  1/45 (2.22%)  0/44 (0.00%) 
Toothache * 1  0/45 (0.00%)  1/44 (2.27%) 
General disorders     
Fatigue * 1  3/45 (6.67%)  2/44 (4.55%) 
Hyperhidrosis * 1  2/45 (4.44%)  1/44 (2.27%) 
Irritability * 1  2/45 (4.44%)  1/44 (2.27%) 
Asthenia * 1  1/45 (2.22%)  1/44 (2.27%) 
Malaise * 1  2/45 (4.44%)  0/44 (0.00%) 
Pyrexia * 1  0/45 (0.00%)  2/44 (4.55%) 
Night sweats * 1  0/45 (0.00%)  1/44 (2.27%) 
Immune system disorders     
Seasonal allergy * 1  0/45 (0.00%)  1/44 (2.27%) 
Infections and infestations     
Fungal infection * 1  0/45 (0.00%)  1/44 (2.27%) 
Herpes Zoster * 1  1/45 (2.22%)  0/44 (0.00%) 
Viral infection * 1  1/45 (2.22%)  0/44 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/45 (0.00%)  1/44 (2.27%) 
Tendon rupture * 1  1/45 (2.22%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/45 (2.22%)  2/44 (4.55%) 
Back Pain * 1  1/45 (2.22%)  1/44 (2.27%) 
Costochondritis * 1  1/45 (2.22%)  0/44 (0.00%) 
Muscle twitching * 1  1/45 (2.22%)  0/44 (0.00%) 
Musculoskeletal stiffness * 1  0/45 (0.00%)  1/44 (2.27%) 
Nervous system disorders     
Headache * 1  10/45 (22.22%)  10/44 (22.73%) 
Dizziness * 1  6/45 (13.33%)  5/44 (11.36%) 
Insomnia * 1  4/45 (8.89%)  4/44 (9.09%) 
Coordination Abnormal * 1  3/45 (6.67%)  1/44 (2.27%) 
Dizziness postural * 1  3/45 (6.67%)  1/44 (2.27%) 
Panic attack * 1  1/45 (2.22%)  1/44 (2.27%) 
Sedation * 1  0/45 (0.00%)  1/44 (2.27%) 
Tension headache * 1  0/45 (0.00%)  1/44 (2.27%) 
Psychiatric disorders     
Suicidal Ideation * 1  9/45 (20.00%)  7/44 (15.91%) 
Depression * 1  6/45 (13.33%)  5/44 (11.36%) 
Anxiety * 1  6/45 (13.33%)  3/44 (6.82%) 
Disturbance in Attention * 1  3/45 (6.67%)  1/44 (2.27%) 
Hypersomnia * 1  1/45 (2.22%)  2/44 (4.55%) 
Depressive symptom * 1  0/45 (0.00%)  1/44 (2.27%) 
Initial insomnia * 1  1/45 (2.22%)  0/44 (0.00%) 
Intentional self-injury * 1  0/45 (0.00%)  1/44 (2.27%) 
Middle insomnia * 1  0/45 (0.00%)  1/44 (2.27%) 
Mood altered * 1  1/45 (2.22%)  0/44 (0.00%) 
Self-injurious ideation * 1  1/45 (2.22%)  0/44 (0.00%) 
Renal and urinary disorders     
Pollakiuria * 1  4/45 (8.89%)  3/44 (6.82%) 
Dysuria * 1  3/45 (6.67%)  0/44 (0.00%) 
Urinary track infeciton * 1  1/45 (2.22%)  0/44 (0.00%) 
Reproductive system and breast disorders     
Libido decreased * 1  1/45 (2.22%)  2/44 (4.55%) 
Menstruation irregular * 1  0/45 (0.00%)  2/44 (4.55%) 
Amenorrhoea * 1  0/45 (0.00%)  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders     
Non-cardiac chest pain * 1  3/45 (6.67%)  1/44 (2.27%) 
Restlessness * 1  1/45 (2.22%)  3/44 (6.82%) 
Nasopharyngitis * 1  1/45 (2.22%)  1/44 (2.27%) 
Sinus congestion * 1  2/45 (4.44%)  0/44 (0.00%) 
Upper respiratory tract infection * 1  0/45 (0.00%)  2/44 (4.55%) 
Cough * 1  0/45 (0.00%)  1/44 (2.27%) 
Musculoskeletal chest pain * 1  0/45 (0.00%)  1/44 (2.27%) 
Pharyngeal erythema * 1  0/45 (0.00%)  1/44 (2.27%) 
Skin and subcutaneous tissue disorders     
Puritus * 1  10/45 (22.22%)  2/44 (4.55%) 
Dry Skin * 1  4/45 (8.89%)  5/44 (11.36%) 
Rash * 1  6/45 (13.33%)  1/44 (2.27%) 
Vascular disorders     
Syncope * 1  1/45 (2.22%)  0/44 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathy Hijek, Associate Director of Clinical Operations
Organization: Duke Clnical Research Institute
Phone: 919-668-8700
EMail: kathy.hijek@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02218736    
Other Study ID Numbers: Pro00052485
HHSN271201200006I ( Other Identifier: NIH/NIMH )
First Submitted: August 15, 2014
First Posted: August 18, 2014
Results First Submitted: November 1, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019