Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD) (NCT06843187) | Clinical Trial Compass
RecruitingPhase 2
Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)
Canada30 participantsStarted 2024-09-25
Plain-language summary
The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are:
* Does Lemborexant help participants improve sleep and reduce insomnia symptoms?
* How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)?
Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder.
Participants will:
* Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg)
* Complete clinical assessments and in-person study visits
* Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs)
* Use a wearable device which will be used to collect and monitor physiological data
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Aged 18 to 70 (inclusive), with a self-reported body mass index (BMI) between 19 and 30 kg/m2 (inclusive);
ā. Meet criteria for primary MDD diagnosis without psychotic symptoms, as defined by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)2, and currently in a MDE, confirmed by the MINI International Neuropsychiatric Interview (MINI)3;
ā. Have not failed more than 2 trials of antidepressant treatments in the current MDE, and have a history of adequate response (clinical outcome rating score of 1 or 2) to at least 1 antidepressant treatment during the current MDE as determined by the Antidepressant Treatment History Form-Short Form (ATHF-SF)4;
ā. Are outpatients;
ā. Did not take non-psychotropic or non-central nervous system (CNS) medications suspected to affect sleep-wake function for at least 4 weeks before starting the study.
ā. Self-reported subjective total sleep time (sTST) ā¤ 6.5 hours, subjective sleep onset latency (sSOL) ā„ 30 minutes, and subjective wake after sleep onset (sWASO) ā„ 45 minutes per night. Time spent in bed (either sleeping or attempting to sleep) must be between 7 and 10 hours per night. Self-reported regular bedtime (i.e., the time the participant gets in bed) between 21:00 and 01:00 and regular wake time (i.e., the time the participant wakes and does not go back to sleep) between 05:00 and 10:00;
. Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ā„ 30 minutes on at least 3 of the 7 nights and/or sWASO ā„ 45 minutes on at least 3 of the 7 nights;
ā. Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary on the 7 most recent mornings before the visit, such that there are no more than 2 nights with time spent in bed of duration \< 7 hours or \> 10 hours;
Exclusion criteria
ā. Have taken or participated in any clinical trial of lemborexant and other drugs with the same mechanism (e.g., daridorexant), regardless of treatment outcome;
ā. Have any known sensitivity to lemborexant or their excipients;
ā. A lifetime history (current or previous) of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychotic symptoms as determined by the MINI;
ā. Women who are pregnant or lactating (documented by a positive beta-human chorionic gonadotropin \[beta-hCG\] or human chorionic gonadotropin \[hCG\] urine test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG or hCG);
ā. Women who are not using an approved and effective method of contraception or family planning during the study. For example, combined estrogen- and progestogen-containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion and ligation, vasectomized partner, sexual abstinence, or two forms of contraception with any barrier method or oral hormones (ie.g., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).
ā. Positive toxicology screening results;
ā. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions or the therapeutic focus 4 weeks before screening and the entire duration of participation;
ā. Have active suicidal intent as determined by a score of 3 (severe suicidality with a clear plan and/or intent) or 4 (very severe: suicidal attempts) on item #3 on the HAM-D-17;