Brexpiprazole for Bipolar Depression

NCT03427892 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 102016-048
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an assessment of the following in patients with bipolar disorder taking brexpiprazole: manic symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder, development of active suicidal or homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe life-threatening medical condition, involuntary psychiatric hospitalization or incarceration.

Conditions

Bipolar Depression

Keywords

mood; bipolar; depression

Outcome Measures

Primary Outcomes (1)

• The Montgomery-Asberg Depression Rating Scale (MADRS)

  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.

  Baseline through week 8

Secondary Outcomes (11)

• Young Mania Rating Scale (YMRS)

  Baseline through week 8

• Rey Auditoy Verbal Learning Test

  Baseline through week 8

• Stroop Task

  Baseline through week 8

• Trail Making Test (TMT)

  Baseline through week 8

• Systematic Assessment For Treatment Emergent Events

  Baseline through week 8

Other Outcomes (1)

• High Sensitivity C-Reactive Protein (Hs-CRP)

  Baseline and at week 8

Study Arms (1)

Brexpiprazole

EXPERIMENTAL

Brexipiprazole will be taken orally beginning at 0.5 mg/day with an increase to 1 mg/day at week 1 and 2 mg/day at week 2. If reduction in mood symptoms does not occur, the dose will increase to 3 mg/day and 4 mg/day.

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.

Also known as: Rexulti

Brexpiprazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient men and women ages 18-65
• Bipolar I or II disorders, currently depressed mood state based on a SCID for DSM-5; Mixed features in DSM-5 are allowed, but those with a Young Mania Rating Scale score ≥ 15 will be excluded
• Baseline MADRS score ≥ 20

You may not qualify if:

• Mood disorders other than bipolar I or II disorders (e.g., bipolar NOS, or cyclothymic disorders, schizophrenia, schizoaffective disorder, or unipolar depression based on the SCID), other disorders, e.g. anxiety disorders, will be allowed
• Current (last 14 days) treatment with an antipsychotic or antidepressant
• History of neuroleptic malignant syndrome or tardive dyskinesia
• Prior history of brexpiprazole use
• Vulnerable populations (e.g., pregnant, nursing, cognitively impaired, incarcerated)
• High risk for suicide defined as \> 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
• Severe or life-threatening medical condition, or laboratory or physical examination findings consistent with serious medical illness (e.g., dangerously abnormal electrolytes)
• Moderate or severe hepatic or renal impairment based on medical history and laboratory analyses
• Taking moderate or strong induces or inhibitors of CYP2D6 or CYP3A4

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Scala M, Biondi L, Fabbri C, Serretti A. Efficacy of Brexpiprazole Combination Therapy on Anhedonia in a Case of Treatment Resistant Bipolar II Depression. J Clin Psychopharmacol. 2023 Sep-Oct 01;43(5):453-455. doi: 10.1097/JCP.0000000000001732. Epub 2023 Jul 14. No abstract available.

  PMID: 37683234 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. E. Sherwood Brown
• Organization: UTexasSouthwestern

Sherwood.Brown@UTSouthwestern.edu

(214) 645-6950

Study Officials

• Sherwood Brown, M.D., Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: February 9, 2018
• Study Start: March 1, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: March 13, 2019
• Results First Posted: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)