Sleep Deprivation for Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stony Brook University
Must not be taking: Stimulants, Antidepressants, Beta-blockers, others
Disqualifiers: Suicide risk, Psychosis, Physical illness, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial involves keeping participants with depression awake to see if it temporarily improves their mood. Brain scans will be used to study changes in brain chemistry. The goal is to understand how sleep patterns affect depression and find better treatments. Sleep deprivation has been investigated as a treatment for depression for a long time and is known to produce next-day antidepressant effects.
Will I have to stop taking my current medications?
Yes, you will need to stop taking medications that affect glutamate levels or circadian rhythms, such as stimulants, anti-epileptics, antidepressants, beta-blockers, hypnotics, melatonin, or medications with glutamateric or GABAergic actions, at least 4 weeks before the study and throughout its duration.
What data supports the effectiveness of the treatment Sleep Deprivation for Depression?
Is sleep deprivation therapy safe for humans?
Sleep deprivation therapy has been studied primarily for depression, and while it can have an antidepressant effect, it may lead to relapses after sleep is resumed. There is no clear evidence of serious safety concerns, but the mechanism of action is not fully understood, and it should be used with caution.13678
How does sleep deprivation treatment differ from other treatments for depression?
Sleep deprivation treatment for depression is unique because it involves keeping patients awake for a period of time, either partially or totally, to improve mood, unlike typical treatments that often involve medication. It is particularly useful for patients who do not respond to drugs, and its effects can be seen quickly, although it often requires additional therapy to maintain the benefits.6791011
Eligibility Criteria
This study is for adults over 18 with Major Depressive Disorder (MDD) currently experiencing a major depressive episode. Participants must be able to consent, sign a form, and score at least 29 on the MADRS. They can't join if they consume too much caffeine or alcohol, have irregular sleep/wake cycles, are pregnant/lactating/planning pregnancy, have MRI/PET scan contraindications, use certain medications/substances including nicotine or are at risk of suicide.Inclusion Criteria
Consent form signed
Score of at least twenty-nine on the MADRS (depressed participants only)
I am 18 years old or older.
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Exclusion Criteria
Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is currently breastfeeding
Participant considered at significant risk for suicide
Any MRI contraindications, including metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Initial Assessment
Participants undergo initial assessment of circadian phase and brain chemistry using PET scans and melatonin measurements
8 weeks
4 overnight stays (in-person)
Sleep Deprivation Therapy
Participants undergo sleep deprivation therapy followed by melatonin and depression severity assessments
1 week
2 overnight stays (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Sleep Deprivation (Behavioural Intervention)
Trial OverviewThe trial investigates how disrupting the sleep/wake cycle affects depression by keeping participants awake for one night. It aims to understand circadian rhythm's role in depression and uses brain scans to study brain chemistry changes. Afterward, depressed participants receive free antidepressant medication.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stony Brook University HospitalStony Brook, NY
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Who Is Running the Clinical Trial?
Stony Brook UniversityLead Sponsor
References
Sleep deprivation as treatment for depression: Systematic review and meta-analysis. [2021]To systematically review evidence on the efficacy and safety of sleep deprivation (SD) as a treatment option for patients with unipolar or bipolar depression.
Sleep deprivation and antidepressant treatment. [2021]The mood-improving effect of sleep deprivation (SD) in depression is even today still not fully understood. Despite the fact that mood and cognitive functions are lowered by prolonged sleep loss and despite convincing data that insomnia is a strong risk factor for subsequent depression,(1) acute SD for one night or even partial SD in the second half of the night improves mood in about 60% of depressed patients the day after.(2,3) In this respect, among alt types of antidepressant treatments, SD elicits the fastest results, faster even than electroconvulsive therapy. Many authors correlate the likelihood of responding to SD with clinical variables. A summary of predictors is listed in Table I.
Periodic sleep deprivation in drug-refractory depression. [2018]For some time it has been known that total and partial sleep deprivation (in the second half of the night) produces an immediate antidepressive effect and a short-term effect of approximately 1-week duration. A 25-day trial is discussed here. 18 endogenous depressives who proved to be refractory to tricyclic antidepressive therapy were treated with periodic sleep deprivation (5 sleep deprivation treatments in the second half of the night at 5-day intervals) under continued drug therapy. The combined treatment led to a better result than would have been expected from drug therapy alone. Some of the sleep deprivation treatments effected an accelerated remission without the efficacy of treatment subsiding. In individual cases recovery occurred after one or a few partial sleep deprivation sessions. Whether in other respects sleep deprivation shortens the course of depressive phases is still unproven.
Microsleep during partial sleep deprivation in depression. [2019]Sleep deprivation (SD) exerts a beneficial effect on mood and sleep in about 60% of depressed patients usually followed by a relapse into depression after the recovery night. Short phases of sleepiness, especially naps in the early morning, may be responsible for this phenomenon.
Polysomnography and criteria for the antidepressant response to sleep deprivation. [2018]One night of total or partial sleep deprivation (SD) produces a temporary remission in 40-60% of patients with major depression. Yet no attempts to determine the optimum response criterion(a) for the antidepressant response to SD have been published.
Sleep deprivation therapy. [2019]This review reports, with as much detail as possible, on the literature relating to therapeutic sleep deprivation (or induced-wakefulness therapy) since it was first described in 1971. The antidepressive effect of sleep deprivation has been substantiated by numerous studies. A series of clinical predictors of response to sleep deprivation are also described. Partial sleep deprivation late in the night is equivalent to total sleep deprivation in terms of therapeutic value and--because of its simpler application--can be regarded today as the sleep deprivation method of choice. The status of sleep deprivation in the overall treatment schedule for depressive disorders is discussed in detail. Numerous findings, some of them contradictory, have been published on the effect of sleep deprivation on biological variables. To date, no unequivocal explanation has been found for the mechanism of action of sleep deprivation.
Sleep deprivation therapy. [2013]Sleep deprivation is a useful therapeutic option in the treatment of depressive disorders, especially in pharmacoresistant disorders. Its therapeutic efficacy in other indications has not, however, been confirmed. According to current knowledge, application of sleep therapy requires concomitant therapy to prevent early relapses of depression. Total sleep deprivation is the classic variant of its clinical use. Partial sleep deprivation has a somewhat less pronounced antidepressant effect, and the duration of sleep deprivation rather than application timing determines its therapeutic effect. The most reliable predictors of sleep deprivation efficacy are marked diurnal fluctuations of depressive mood, patient locomotor activity, and limbic hyperactivity in the central nervous system. The mechanism of the antidepressant effect of sleep deprivation remains unknown.
The biological basis of an antidepressant response to sleep deprivation and relapse: review and hypothesis. [2005]Sixty-one papers involving over 1,700 subjects have documented that over half of depressed patients experience an antidepressant response to sleep deprivation. Eighty-three percent of unmedicated depressed patients who had an antidepressant response to sleep deprivation relapsed after one night of sleep. Short naps can also activate severe relapses. The authors suggest that these phenomenological observations concerning relapse with a night of sleep or with naps after successful sleep deprivation would be compatible with the existence of a sleep-associated depressogenic process.
[Total and partial sleep deprivation in the treatment of depression: preliminary communication]. [2006]Sleep deprivation (SD) has been proved to be an effective measure of antidepressive treatment (especially in endogenous depression). In a new study, 125 SD were examined on 93 depressed patients. The therapeutic benefit of SD on endogenous depression consists not only of the nightly clear up but also of provoking or improving a typical day wave the day after DS. A period of at least 36 h is necessary to survey the total effect of this method. The best results are achieved in patients with severe endogenous depression, especially in those with the typical day wave and distinct somatic symptoms. The effect of partial SD (for the second half of the night) is almost the same as that of total SD. The advantages of partial SD are: the patient can stand it easier, more often, and - in the company of a suited person - even at home. Finally, it is less complicate in clinical routine than selective REM-deprivation.
Meta-analysis of sleep deprivation in the acute treatment of bipolar depression. [2022]Sleep deprivation (SD) is an antidepressant intervention with multiple administration formats that has been investigated primarily with uncontrolled clinical trials and qualitative reviews of the literature. The validity and applicability of these findings to the treatment of bipolar depression (BPD) is uncertain.
Usage of Therapeutic Sleep Deprivation: A Survey in Psychiatric Hospitals in Austria, Germany, and Switzerland. [2020]Objective: Therapeutic sleep deprivation (SD) is a nonpharmacological treatment that is used most often for depression. The aim of this study was to examine the pattern of use of SD in psychiatric hospitals in Austria, Germany, and Switzerland. Methods: A questionnaire about perceived usage of SD was sent by mail to all 511 psychiatric hospitals in the three countries. Nonresponders were asked to answer the questionnaire by phone. We achieved a response rate of 75.3%. Results: SD was recommended by 61.3% of all hospitals. Despite this degree of recommendation, nearly two thirds of the psychiatric hospitals had not treated a patient with SD during the last 12 months. Of the respondents, 59.5% considered SD to be indicated for major depressive disorder, 17.7% for bipolar depression, and 7.8% for other indications. SD was administered most frequently in inpatient settings and in combination with other therapies. Total SD (patients kept awake entire night) and partial late SD (patients kept awake in second half of night) were judged equally effective. Of the hospitals, 53.0% reported having seen hypomania and 13.2% manic episodes as side effects (rates do not represent actual incident rates). Conclusion: The lack of large controlled studies for SD with its different forms of treatment probably still hinders a broader use of the therapy. Therefore, further efforts should be undertaken to provide high-quality scientific evidence for the usage of SD.