Health TrialsbyHealthPanel

Brexpiprazole Treatment for Bipolar I Depression

ConditionBipolar Depression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDouglas Mental Health University Institute

About this trial

Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of life in this clinical population. There is robust evidence that individuals with BD have neurocognitive deficits (especially in memory and executive functioning domains) compared to the healthy population. These deficits are present in all mood states and can greatly affect patients' functional capacity, often more so than mood symptoms themselves. Many pharmacological treatments for BD adversely affect cognition, and those that are beneficial can be difficult to use. There is thus a pressing need to identify a safe, easy-to-use medication that can target both cognitive deficits and depressive symptoms in BD. It is expected that Brexpiprazole adjunctive treatment will be efficacious in treating BD type I and type II depression by improving mood symptoms, as well as cognitive capacity and global functioning, and that such changes will be accompanied by concurrent alterations in associated brain structures.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18-75

Male or female

Bipolar Disorder type I or type II

Current treatment-resistant depressive episode (with MADRS >/= 24 and item 2 (reported sadness) >/= 3) for a minimum of 2 weeks but </= 52 weeks at screening visit and baseline visit

Disqualifiers

Is at high risk of suicide as defined by a score of >/= 3 to item 10 of MADRS and/or in the clinical opinion of the investigator

Hypo(mania) episode with YMRS >/= 8

Psychotic symptoms as defined by a score of >/= 4 to item 8 (content) of YMRS and/or in the opinion of the investigator

Is treated with fluoxetine OR carbamazepine

Trial design

Design model

Single group

Treatments tested in this trial

  • Brexpiprazole

    Drug

    Adjunctive variable dose (1-3 mg/day) Brexpiprazole

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: PatientExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline Depressive Symptoms as Assessed by MADRS at 8 weeks

Percentage of response to treatment, as defined by a 50% improvement of depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 8 weeks. The overall MADRS score ranges from 0 to 60, where a higher score indicates more severe depression.

Time frame
8 weeks

Secondary outcomes

1

Change from Baseline Global Functioning as Assessed by FAST at 8 weeks

Differential scores from baseline on Functioning Assessment Short Test (FAST) after 8 weeks of treatment. The overall FAST score ranges from 0 to 72, where a higher score indicates more severe difficulties.

Time frame
8 weeks
2

Change from Baseline Global Functioning as Assessed by FAST at 12 weeks

Differential scores from baseline on Functioning Assessment Short Test (FAST) after 12 weeks of treatment. The overall FAST score ranges from 0 to 72, where a higher score indicates more severe difficulties.

Time frame
12 weeks
3

Change from Baseline Global Functioning as Assessed by FAST at 6 months

Differential scores from baseline on Functioning Assessment Short Test (FAST) after 6 months of treatment. The overall FAST score ranges from 0 to 72, where a higher score indicates more severe difficulties.

Time frame
6 months
4

Change from Baseline Global Functioning as Assessed by CPFQ at 8 weeks

Differential scores from baseline on Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) after 8 weeks. The overall CPFQ score ranges from 0 to 42, where a higher score indicates poorer functioning.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Douglas Mental Health University Institute

Lead sponsor

McMaster University

Collaborator

Jewish General Hospital

Collaborator

Source ClinicalTrials.gov
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