Effects of adjunctive brexpiprazole on sleep-wake and circadian parameters in youth with depressive syndromes – an open-label, mechanistic study

niversity of Sydney0 个研究点目标入组 1 人开始时间: 2019年10月22日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•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.

•- 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

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