The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients

This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Depressive Disorder Depressive Disorder, Major Dyssomnias Mental Disorders Mood Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California, Irvine, Irvine, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

include:

Subjects must be English speaking
Subjects must have either bipolar or unipolar depression diagnosis or be a normal control.
Subjects must be between : 18 to 75

Non-English speaking subjects will be excluded since scales for measuring depression have not been validated in languages other than English.

Exclusion criteria

include:

Suicidality, or psychosis
Unstable medical conditions
Epilepsy, serious head injury, or other significant neurological disorders
Dementia, mental retardation (moderate or severe), coma
Prior exposure to radiation which might cause the subject to exceed standard guidelines
Substance abuse or alcoholism in the past six months
Unreliability or inability to adhere to the requirements of the study
Irregular sleep-wake schedules (nightshift, jet lag)
Use of CNS medications which may affect sleep or functional brain imaging (i.e., use of sleeping pills, antidepressants or other mood stabilizers or other medications which may affect the sleep EEG)
Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders
Donation or loss of blood (>400 ml) within the past month
Current or very recent intercurrent illnesses, painful conditions or other disorders, which in the judgement of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for the subject.
Hamilton Rating Scale of Depression (HRSD-17 items)<17 unless subject is a normal control subject.
Pregnancy or breast feeding
Individuals who would be unable to undergo a magnetic resonance imaging (MRI) scan, for example, individuals who suffer from claustrophobia, or who have metal clips in their body.
Unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to PET scans.
Patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other SSRI's such as Paxil or Prozac
Subjects with diagnosis of eating disorder/bulimia

Treatment and study plan

chronobiological augmentation

Other

Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days

sertraline, lithium

Drug

Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.

Mood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks.

Other names: Zoloft, Lithium

one night of sleep deprivation and two FDG PET scans

Radiation

MDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility.

Primary outcomes

Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version

Time frame: within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy

Difference in HRSD between the chronobiological augmentation therapy and medication only groups across the first 7 days, and up to 7 weeks of treatment. The 21-item HRSD has a range of 0 to 66, with a higher score indicating more severe depression.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

University of California, San Diego

Registry information

Important dates

Study start: 2001
Primary completion: 2011
Study completion: 2011
First posted: Dec 27, 2007
Registry last updated: Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed