Trial · NCT02218736

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

NCT02218736, Phase 2, Completed, Duke University; results first posted 2019-01-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fast-Fail Trials in Mood and Anxiety Spectrum Disorders; Kappa Opioid Receptor Phase 2a. Trials, record NCT02218736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02218736

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fast-Fail Trials in Mood and Anxiety Spectrum Disorders; Kappa Opioid Receptor Phase 2a
NCT number: NCT02218736
Status: Completed
Phases: Phase 2
Enrollment: 163 participants, actual
Lead sponsor: Duke University
Conditions: ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Interventions: CERC-501, placebo
First posted: 2014-08-18
Last updated: 2019-01-08
Results first posted: 2019-01-08

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Ventral Striatal Activation Occurring in Anticipation of Reward During the Monetary Incentive Delay Task Measured by fMRI	baseline, Week 8	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.
Secondary	Clinical Anhedonia Measured by the Snaith-Hamilton Pleasure Scale (SHAPS; Total Score)	8 weeks	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.
Secondary	Change in Behavioral Measure of Anhedonia Using the Probabilistic Reward Task	baseline, Week 8	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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Ventral Striatal Activation Occurring in Anticipation of Reward During the Monetary Incentive Delay Task Measured by fMRI	baseline, Week 8	The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.	Z score	MEAN
SECONDARY	Clinical Anhedonia Measured by the Snaith-Hamilton Pleasure Scale (SHAPS; Total Score)	8 weeks	The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.	score on a scale	MEAN
SECONDARY	Change in Behavioral Measure of Anhedonia Using the Probabilistic Reward Task	baseline, Week 8	The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.	Ratio (Response Bias Score)	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Ventral Striatal Activation Occurring in Anticipation of Reward During the Monetary Incentive Delay Task Measured by fMRI	CERC-501	0.718	95% Confidence Interval 0.487 to 0.950	Z score
Change in Ventral Striatal Activation Occurring in Anticipation of Reward During the Monetary Incentive Delay Task Measured by fMRI	Placebo	0.331	95% Confidence Interval 0.103 to 0.559	Z score
Clinical Anhedonia Measured by the Snaith-Hamilton Pleasure Scale (SHAPS; Total Score)	CERC-501	30.777	95% Confidence Interval 29.547 to 32.007	score on a scale
Clinical Anhedonia Measured by the Snaith-Hamilton Pleasure Scale (SHAPS; Total Score)	Placebo	32.363	95% Confidence Interval 31.157 to 33.568	score on a scale
Change in Behavioral Measure of Anhedonia Using the Probabilistic Reward Task	CERC-501	0.034	95% Confidence Interval -0.019 to 0.087	Ratio (Response Bias Score)
Change in Behavioral Measure of Anhedonia Using the Probabilistic Reward Task	Placebo	0.019	95% Confidence Interval -0.030 to 0.068	Ratio (Response Bias Score)

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CERC-501	45
Overall Study	STARTED	Placebo	44
Overall Study	COMPLETED	CERC-501	33
Overall Study	COMPLETED	Placebo	35
Overall Study	NOT COMPLETED	CERC-501	12
Overall Study	NOT COMPLETED	Placebo	9

Source ClinicalTrials.gov

Adverse events144

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	CERC-501	13	45
other	Diarrhea	Gastrointestinal disorders	Placebo	8	44
other	Headache	Nervous system disorders	CERC-501	10	45
other	Headache	Nervous system disorders	Placebo	10	44
other	Suicidal Ideation	Psychiatric disorders	CERC-501	9	45
other	Suicidal Ideation	Psychiatric disorders	Placebo	7	44
other	Puritus	Skin and subcutaneous tissue disorders	CERC-501	10	45
other	Puritus	Skin and subcutaneous tissue disorders	Placebo	2	44
other	Depression	Psychiatric disorders	CERC-501	6	45
other	Depression	Psychiatric disorders	Placebo	5	44

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CERC-501	0	45
Total, all-cause mortality	Placebo	0	44
Total, other adverse events	CERC-501	34	45
Total, other adverse events	Placebo	32	44
Total, serious adverse events	CERC-501	0	45
Total, serious adverse events	Placebo	0	44

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24071566	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CERC-501 vs Placebo: deaths from any cause	Trial comparisons
CERC-501 vs Placebo: serious adverse events	Trial comparisons

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Monetary Incentive Delay	Primary outcome	ConductCognition
Probabilistic Reward Task	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02218736

GET https://conductscience.org/api/trials/v1/NCT02218736/events?page=2

API reference For AI assistants