Wake Therapy in the Treatment of Depression

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot study seeks to replicate previous findings that sleep deprivation results in marked improvement in depression symptoms, as well as to test whether concurrent treatment with Light Therapy and Lithium are successful in locking in and maintaining therapeutic effects in both bipolar and unipolar depressed subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression

NCT02750631

Unipolar Depression

COMPLETED NA

Are Bright Lights and Regulated Sleep Effective Treatment for Depression?

NCT03010488

Sleep Phase Rhythm Disturbance Sleep Deprivation

COMPLETED NA

Combining Light Therapy and CPAP in Depression

NCT06781593

Major Depression Sleep Architecture Obstructive Sleep Apnea +3 more

RECRUITING NA

Chronotherapy Randomized Controlled Trial

NCT02176824

Major Depressive Disorder Bipolar Depression Suicidal Ideation

TERMINATED NA

Light Therapy in Modulating the Clinical Phenotype of Patients With Primary and Comorbid Chronic Insomnia.

NCT05797324

Insomnia Chronic

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Both refractory depression and bipolar depression are difficult to treat. A night of complete sleep deprivation has been shown to result in marked improvement in 60% of depressed patients, although maintenance of therapeutic effects have not been sustained with wake therapy alone. This pilot study will assess the effectiveness of wake therapy in treating both bipolar depression (5 participants)and major depression (5 participants), as well as the effectiveness of concomitant light therapy and lithium in maintaining the therapeutic effects. Participants will undergo direct observation in the hospital for one week during initial treatment with alternating nights of sleep deprivation, light therapy and lithium treatment, and then will be seen weekly as outpatients for 6 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an "open label" study so all participants know what the treatment is.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wake Therapy + light box +/- lithium

* Bipolar patients must take lithium; others do not take lithium
* all patients are hospitalized for a week during which they do not sleep on alternating nights
* for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations

Group Type EXPERIMENTAL

Wake Therapy

Intervention Type BEHAVIORAL

Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.

light box

Intervention Type DEVICE

use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire

Lithium

Intervention Type DRUG

For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wake Therapy

Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.

Intervention Type BEHAVIORAL

light box

use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire

Intervention Type DEVICE

Lithium

For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Day Light Lithobid, lithium carbonate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. current major depressive episode (MDD, BP-I or BP-II)
2. if not BP-I or BP-II, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms
3. If BP-I or BP-II, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate
4. physically healthy
5. age 18-75
6. not taking current antidepressants(antidepressants deemed effective will not be discontinued

Exclusion Criteria

1. medically unstable condition
2. past intolerance of lithium (bipolar only)
3. history of (or current) psychosis or epilepsy
4. current (past six months) drug or alcohol abuse/dependence
5. pregnancy
6. contraindication to lithium (bipolar only)
7. significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration)
8. currently taking effective antidepressant
9. cognitive dysfunction
10. Parkinson's Disease
11. Thyroid Stimulating Hormone \> 5 milli International Units/Liter
12. left ventricular hypertrophy
13. symptomatic mitral valve prolapse
14. abnormal creatinine

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No