Trial · NCT03427892

Brexpiprazole for Bipolar Depression

NCT03427892, Phase 4, Completed, University of Texas Southwestern Medical Center; results first posted 2019-03-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Brexpiprazole for Bipolar Depression. Trials, record NCT03427892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03427892

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Trial

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

Title: Brexpiprazole for Bipolar Depression
NCT number: NCT03427892
Status: Completed
Phases: Phase 4
Enrollment: 21 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Bipolar Depression
Interventions: Brexpiprazole
First posted: 2018-02-09
Last updated: 2019-03-13
Results first posted: 2019-03-13

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	The Montgomery-Asberg Depression Rating Scale (MADRS)	Baseline through week 8	The Montgomery-Asberg Depression Rating Scale is used to assess depressive symptom severity. There are 10 items and each item is rated from 0 to 6 (increasing severity) based on the assessment of symptoms within the past 7 days. Scoring is assisted by descriptive anchors that serve as useful guides at 0,2,4, 8. Odd numbers (1,3,5) between the descriptive anchors are also meant to be scored. Highest possible MADRS score is 60. Lowest possible MADRS score is 0. MADRS is scored by taking the sum of the scores for each item. A higher score is indicative of more acute depressive symptoms.
Secondary	Young Mania Rating Scale (YMRS)	Baseline through week 8	Young Mania Rating Scale is an observer-rated measure of mania symptoms. It has 11 items and each items has 5 defined anchor points with increasing severity that describe the symptom characteristics. YMRS is scored by taking sum of the scores for the 11 items. A higher score indicative of more acute manic symptoms. Seven of the items are scored between 0 and 4. Four items allow for scoring between anchor points (ranging 1 to 8). Maximum score is 60 and minimum score is 0.
Secondary	Rey Auditoy Verbal Learning Test	Baseline through week 8	Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.
Secondary	Stroop Task	Baseline through week 8	The Stroop task evaluates attention, speed, and accuracy of thinking. Stroop task consists of three separate trials: word, color, and color-word (CW) naming. For each trial, a raw score (correct number of words named) is recorded. The raw score for each trial is converted to a T-score based on participant's age and education level. The possible T-scores range from 15-85 for the word trial, 8-92 for the color trial, and 3-98 for the color-word trial. The interference score (Inter) is also derived from the color-word score, with T-scores ranging from 21-80. Higher numbers indicate better performance. The entered values represent T-scores.
Secondary	Trail Making Test (TMT)	Baseline through week 8	The Trail Making Test (TMT) measures attention, speed, and accuracy. TMT consists of two parts: Trails A and Trails B. The performance on each test is measured in seconds and represents how quickly a participant can connect the numbers (Trails A) and the numbers and letters (Trails B) together. The number of seconds it takes to complete each part of TMT is converted to a T-score based on gender, age, race, and education. The T-scores range from 0-100 with higher scores indicating better (faster) performance. The entered data are presented as T-Scores.
Secondary	Systematic Assessment For Treatment Emergent Events	Baseline through week 8	The Systematic Assessment for Treatment Emergent Effects (SAFTEE) is a self-report scale used in clinical trials and is designed to evaluate the degree to which each possible side effect is bothersome to a participant. There are 55 items on the scale (each item represents a different side effect), with each item rated on a 4-point scale such as "not bothersome - 0 (zero)", "mildly bothersome - 1", "moderately bothersome - 2", "severely bothersome - 3". The total possible range of scores on the scale is 0-165. The higher scores indicate a higher degree of being bothered by various side effects.
Secondary	Columbia Suicide Severity Rating Scale	Baseline through week 8	The Columbia Suicide Severity Rating Scale (C-SSRS) is a structured interview and rating scale used to measure suicidal thoughts and behaviors. Actual attempts, interrupted attempts, and aborted attempts are measured as positive integers (zero and above). The minimum value for the actual, interrupted, and aborted attempt is zero (reflecting no past suicidal behavior). There is no maximum scale value, as the number of attempts differs for each participant. The entered values represent the average number of actual, interrupted, and aborted attempts in the group. Higher values reflect a higher number of attempts experienced by each participant (equivalent to a worse outcome).
Secondary	Abnormal Involuntary Movement Scale	Baseline through week 8	The Abnormal Involuntary Movement Scale (AIMS) is an assessment of movements to determine any long-term drug induced movement disorders.There are 10 items on the scale with scores ranging from 0-4 (0 None/Normal, 1 minimal, 2 mild, 3 moderate,4 severe). 4 items assess facial and oral movements, 2 items measure extremity movements, 1 item measures trunk movements, and 3 items measure global judgments regarding symptoms assessed. A total score is the sum of scores for items assessing facial and oral movements, extremity movements, and trunk movement (scores ranging from 0-28), with 0 being the lowest score, and 28 being the highest score. A higher score is indicative of a higher severity in symptomatology.
Secondary	Barnes Akathisia Scale	Baseline through week 8	The Barnes Akathisia Scale (BAS) is an assessment of movements to determine any short-term drug-induced movement disorders. There are 5 items.Items 1-3 are rated from a scale of 0-3 with 0 indicating the least severity, and 3 indicating the highest severity of symptoms. Item 4 is a global assessment of symptoms assessed and the severity is assessed on a scale of 0-5, with 0 indication least severity and 5 indicating the most severity.The total score is the sum of all the item scores (scores ranging from 0-14).With higher scores reflecting worse outcome.
Secondary	Simpson Angus Scale	Baseline through week 8	The Simpson Angus Scale (SAS) measured drug-induced movement side effects. There are 10 items on the scale, with each item scored on a scale of 0-4 (least to most severe). The total possible range of scores across all items is 0-40, with higher scores indicative of worse outcome.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	The Montgomery-Asberg Depression Rating Scale (MADRS)	Baseline through week 8	score on a scale	MEAN
SECONDARY	Young Mania Rating Scale (YMRS)	Baseline through week 8	score on a scale	MEAN
SECONDARY	Rey Auditoy Verbal Learning Test	Baseline through week 8	T-scores	MEAN
SECONDARY	Stroop Task	Baseline through week 8	T-scores	MEAN
SECONDARY	Trail Making Test (TMT)	Baseline through week 8	T-scores	MEAN
SECONDARY	Systematic Assessment For Treatment Emergent Events	Baseline through week 8	score on a scale	MEAN
SECONDARY	Columbia Suicide Severity Rating Scale	Baseline through week 8	attempts	MEAN
SECONDARY	Abnormal Involuntary Movement Scale	Baseline through week 8	score on a scale	MEAN
SECONDARY	Barnes Akathisia Scale	Baseline through week 8	score on a scale	MEAN
SECONDARY	Simpson Angus Scale	Baseline through week 8	score on a scale	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group52

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

Outcome	Group	Category	Value	Spread	Units
The Montgomery-Asberg Depression Rating Scale (MADRS)	Brexpiprazole	MADRS Baseline	31.95	Standard Deviation 10.33	score on a scale
The Montgomery-Asberg Depression Rating Scale (MADRS)	Brexpiprazole	MADRS Week 4	9.95	Standard Deviation 8.28	score on a scale
The Montgomery-Asberg Depression Rating Scale (MADRS)	Brexpiprazole	MADRS Week 8	10.95	Standard Deviation 9.59	score on a scale
Young Mania Rating Scale (YMRS)	Brexpiprazole	YMRS Baseline	4.63	Standard Deviation 3.22	score on a scale
Young Mania Rating Scale (YMRS)	Brexpiprazole	YMRS Week 4	4.21	Standard Deviation 3.97	score on a scale
Young Mania Rating Scale (YMRS)	Brexpiprazole	YMRS Week 8	4.42	Standard Deviation 5.36	score on a scale
Rey Auditoy Verbal Learning Test	Brexpiprazole	RAVLT T Score Baseline	37.47	Standard Deviation 16.67	T-scores
Rey Auditoy Verbal Learning Test	Brexpiprazole	RAVLT T Score Week 4	37.79	Standard Deviation 10.36	T-scores
Rey Auditoy Verbal Learning Test	Brexpiprazole	RAVLT T Score Week 8	40.42	Standard Deviation 11.97	T-scores
Rey Auditoy Verbal Learning Test	Brexpiprazole	RAVLT Delay Baseline	39.74	Standard Deviation 13.23	T-scores

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Brexpiprazole	21
Overall Study	COMPLETED	Brexpiprazole	19
Overall Study	NOT COMPLETED	Brexpiprazole	2

Source ClinicalTrials.gov

Adverse events6

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	Restlessness	Nervous system disorders	Brexpiprazole	2	19	2
other	Eye twitch	Eye disorders	Brexpiprazole	2	19	2
other	Dizziness	Nervous system disorders	Brexpiprazole	2	19	2
other	Jaw clenching	Musculoskeletal and connective tissue disorders	Brexpiprazole	1	19	1
other	Weight Gain	Metabolism and nutrition disorders	Brexpiprazole	1	19	1
other	Migraines	Nervous system disorders	Brexpiprazole	1	19	1

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brexpiprazole	0	19
Total, other adverse events	Brexpiprazole	9	19
Total, serious adverse events	Brexpiprazole	0	19

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37683234	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 comparisons0

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

None in this release.

Tests4

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
Stroop Color-Word Test	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Trail Making Test B	Secondary outcome	ConductCognition
Verbal Learning	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/NCT03427892

GET https://conductscience.org/api/trials/v1/NCT03427892/results?page=2

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