Does supplemental brexpiprazole affect sleep-wake and circadian parameters in youth with depressive syndromes?

Phase 4

• Conditions: circadian parameters; depression; Mental Health - Other mental health disorders; Mental Health - Depression

• Registration Number: ACTRN12619001456145
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-22
• Study Completion: 2024-05-09
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Aged 18-30
- Major Depressive Disorder diagnosis according to DSM-5 criteria using the Structured Clinical Interview for DSM-5 (SCID)
- Current Major Depressive Episode of moderate severity as indexed by QIDS-CR score greater than or equal to 11 at two assessments 2 weeks apart
- Failure to respond to at least one adequate trial (i.e., at least 4 weeks) of a pharmacological therapy for the current episode
- Current antidepressant treatment must include an SSRI or SNRI (citalopram, fluoxetine, paroxetine, sertraline, escitalopram, venlafaxine, desvenlafaxine, duloxetine) for at least 6 weeks, at a stable dose for 2 weeks prior to study initiation.
- Perturbed 24-hour sleep-wake cycle as evidenced by: delayed sleep onset; delayed sleep offset; disrupted sleep; high day-to-day variability of sleep-wake; non-restorative sleep; or daytime fatigue.

Exclusion Criteria

- Receipt of other adjunctive antipsychotic medication for the current episode
- Use of medications that affect sleep, melatonin, circadian rhythms or alertness
- Evidence of other sleep, respiratory (e.g., sleep apnoea), neurological or primary medical conditions that could contribute to sleep-wake dysfunction
- A primary psychotic diagnosis (e.g. schizophrenia)
- Acute suicidal behaviour (score of 6 on Comprehensive Assessment of At-Risk Mental States (CAARMS) item 7.3)
- Significant alcohol or other substance misuse or substance dependence
- Regular shift-work within 60-days prior to entry into the study.
- Recent transmeridian travel (participants will be required to wait three days for each jet lag hour before entering the study)
- A history of previous hypersensitivity to brexpiprazole or any of the excipients.
- Taking moderate to strong CYP2D6 or CYP3A4 inhibitors (e.g., quinidine, ketoconazole) or strong CYP3A4 inducers (e.g., rifampicin)
- Pregnancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be depressive symptoms assessed by QIDS-CR total score (minus sleep items) <br>[ Week 8 from Baseline assessment];Primary circadian variable of interest is an actigraphy parameters of Sleep onset time measured by actigraphy recordings using a wrist-worn GENEActiv actigraph.<br><br>[ 2-week period prior to baseline and prior to week 8 ];In-lab circadian measure: <br>- Dim Light Melatonin Onset (DLMO) timing, assessed by taking a saliva sample every hour as per the study in-lab circadian assessment protocol. <br><br>[ Saliva samples will be collected every hour over an 8-hour period (i.e. until 2-hours after habitual sleep onset) during the in-lab circadian assessments at Baseline and Week 8 timepoints. ]