Trial · NCT02466685

Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients

NCT02466685, Phase 2, Completed, Herbert Meltzer; results first posted 2023-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients. Trials, record NCT02466685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02466685

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Trial

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

Title: Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients
NCT number: NCT02466685
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: Herbert Meltzer
Conditions: Bipolar Disorder
Interventions: JNJ-18038683, Placebo
First posted: 2015-06-09
Last updated: 2023-11-14
Results first posted: 2023-07-03

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	The 8-week Evaluation of Verbal Fluency Performance After Randomization	Baseline and week 8	Change in a score of Verbal Fluency from baseline to week 8 A higher amount of change represents a better outcome V.F., as a primary outcome measure, is one of the Cognitive battery tests used to evaluate neurocognitive functions, i.e., speed of processing, attention/vigilance, working memory, verbal learning, and visual learning. The way to calculate the score: the participant is asked to produce as many words as possible from a category in a given time and each correct word gets 1 score Min raw score:0 Max raw score:60
Secondary	Montgomery-Asberg Depression Rating Scale	Baseline to week 8	Secondary outcome measures will include mean changes of the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week 8. The MADRS will be utilized to assess a subject's level of depressive symptoms and must be administered using a structured interview guide. This scale consists of 10 items, each with seven defined grades of severity (zero to six), and min score of 0, and a max score of 60. Higher values represent a worse outcome. Notably, mean changes were not statistically significant in both groups.
Secondary	Clinical Global Impression Severity of the Subject With Bipolar Disorder Scale( CGI-S in BP) Change From Baseline to Week 8	Baseline to 8 weeks	We assessed the clinical global Impression severity (CGI-S) scores change in JNJ-18038683 and the placebo group as an additional endpoint. The scale rates the subject's Severity of Illness (CGI-BPSeverity: mania, depression, and overall bipolar illness). Using ANCOVA analysis to assess changes from baseline to week 8, based on the least-square means and standard errors was the method. CGI-S scores range from 0 to 7. Higher scores mean a worse outcome.

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	The 8-week Evaluation of Verbal Fluency Performance After Randomization	Baseline and week 8	Although the total number of participants in each group was 30, the analysis was only done for those who had completed all study visits.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Montgomery-Asberg Depression Rating Scale	Baseline to week 8	Although the total number of each group was 30, only data of the participants who completed week eight were analyzed on MADRS.~ANCOVA analysis for comparing the result of the Montgomery Asberg Depression rating scale between JNJ-18038683 and the placebo group, based on the least-square means and standard errors, will be the statistical method. The Missing data will be imputed by MMRM.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression Severity of the Subject With Bipolar Disorder Scale( CGI-S in BP) Change From Baseline to Week 8	Baseline to 8 weeks	Although the total number of participants in each group was 30, the analysis was only done for those who had completed all study visits. Using ANCOVA analysis to assess changes from baseline to week 8, based on the least-square means and standard errors was the method.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Category	Value	Spread	Units
The 8-week Evaluation of Verbal Fluency Performance After Randomization	JNJ-18038683		39.44	Standard Error 1.31	score on a scale
The 8-week Evaluation of Verbal Fluency Performance After Randomization	Placebo		41.12	Standard Error 1.33	score on a scale
Montgomery-Asberg Depression Rating Scale	Participants Receiving JNJ-18038683 Tablet From Baseline to week8	MADRS baseline score	2.93	Standard Error 0.71	score on a scale
Montgomery-Asberg Depression Rating Scale	Placebo	MADRS baseline score	3.37	Standard Error 0.71	score on a scale
Montgomery-Asberg Depression Rating Scale	Participants Receiving JNJ-18038683 Tablet From Baseline to week8	MADRS week 8 score	6.63	Standard Error 1.26	score on a scale
Montgomery-Asberg Depression Rating Scale	Placebo	MADRS week 8 score	5.89	Standard Error 1.26	score on a scale
Clinical Global Impression Severity of the Subject With Bipolar Disorder Scale( CGI-S in BP) Change From Baseline to Week 8	JNJ-18038683	CGI-S baseline score	2.78	Standard Error 0.19	score on a scale
Clinical Global Impression Severity of the Subject With Bipolar Disorder Scale( CGI-S in BP) Change From Baseline to Week 8	Placebo	CGI-S baseline score	2.63	Standard Error 0.19	score on a scale
Clinical Global Impression Severity of the Subject With Bipolar Disorder Scale( CGI-S in BP) Change From Baseline to Week 8	JNJ-18038683	CGI-S week 8 score	2.59	Standard Error 0.19	score on a scale
Clinical Global Impression Severity of the Subject With Bipolar Disorder Scale( CGI-S in BP) Change From Baseline to Week 8	Placebo	CGI-S week 8 score	2.37	Standard Error 0.19	score on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	JNJ-18038683	30
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	JNJ-18038683	22
Overall Study	COMPLETED	Placebo	26
Overall Study	NOT COMPLETED	JNJ-18038683	8
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events28

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	Events
other	Non-Serious Adverse Events	Psychiatric disorders	JNJ-18038683	6	30	7
other	Non-Serious Adverse Events	Psychiatric disorders	Placebo	0	30	0
other	Non-Serious Adverse Events	Gastrointestinal disorders	JNJ-18038683	0	30	0
other	Non-Serious Adverse Events	Gastrointestinal disorders	Placebo	2	30	5
other	Non-Serious Adverse Events	Respiratory, thoracic and mediastinal disorders	JNJ-18038683	0	30	0
other	Non-Serious Adverse Events	Respiratory, thoracic and mediastinal disorders	Placebo	2	30	2
other	Non-Seriuos Adverse event	Psychiatric disorders	JNJ-18038683	0	30	0
other	Non-Seriuos Adverse event	Psychiatric disorders	Placebo	2	30	2
other	Non-Serious Adverse Events	General disorders	JNJ-18038683	3	30	3
other	Non-Serious Adverse Events	General disorders	Placebo	0	30	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	JNJ-18038683	0	30
Total, all-cause mortality	Placebo	0	30
Total, other adverse events	JNJ-18038683	6	30
Total, other adverse events	Placebo	6	30
Total, serious adverse events	JNJ-18038683	3	30
Total, serious adverse events	Placebo	1	30

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39250138	DERIVED

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
JNJ-18038683 vs Placebo: deaths from any cause	Trial comparisons
JNJ-18038683 vs Placebo: serious adverse events	Trial comparisons

Tests1

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
Verbal Fluency	Primary outcome

Source 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/NCT02466685

GET https://conductscience.org/api/trials/v1/NCT02466685/events?page=2

API reference For AI assistants