Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2018

Intervention(s) in this Clinical Trial

• Other: chronobiological augmentation
  • 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
• Drug: sertraline, lithium
  • 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.
• Radiation: one night of sleep deprivation and two FDG PET scans
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • chronobiological augmentation group
• Experimental: 2
  • medication only group
• Experimental: MDD Mechanism

Primary Measures

• Hamilton Rating Score for Depression
  • Time Frame: within the first seven weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy
    Safety Issue?: No

Inclusion Criteria:

Inclusion criteria include:

• 1. Subjects must be English speaking
• 2. Subjects must have either bipolar or unipolar depression diagnosis or be a normal control.
• 3. 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:

Exclusion criteria include:

• 1. Suicidality, or psychosis
• 2. Unstable medical conditions
• 3. Epilepsy, serious head injury, or other significant neurological disorders
• 4. Dementia, mental retardation (moderate or severe), coma
• 5. Prior exposure to radiation which might cause the subject to exceed standard guidelines
• 6. Substance abuse or alcoholism in the past six months
• 7. Unreliability or inability to adhere to the requirements of the study
• 8. Irregular sleep-wake schedules (nightshift, jet lag)
• 9. 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)
• 10. Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders
• 11. Donation or loss of blood (>400 ml) within the past month
• 12. 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.
• 13. Hamilton Rating Scale of Depression (HRSD-17 items)<17 unless subject is a normal control subject.
• 14. Pregnancy or breast feeding
• 15. 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.
• 16. Unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to PET scans.
• 17. Patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other SSRI's such as Paxil or Prozac
• 18. Subjects with diagnosis of eating disorder/bulimia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of California, Irvine

Overall Clinical Trial Officials and Contacts

Barry F Chaitin, M.D. Study Chair University of California, Irvine  

Overall Contact: Joseph C Wu, M.D. 949-824-7867 jcwu@uci.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00581009

Study ID Number: HS#2001-1616

ClinicalTrials.gov Identifier: NCT00581009

Health Authority: United States: Institutional Review Board