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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581009
Recruitment Status : Unknown
Verified November 2010 by University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : December 27, 2007
Last Update Posted : November 2, 2010
University of California, San Diego
Information provided by:
University of California, Irvine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Bipolar Disorder Other: chronobiological augmentation Drug: sertraline, lithium Radiation: one night of sleep deprivation and two FDG PET scans Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
Study Start Date : March 2001
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: 1
chronobiological augmentation group
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
Experimental: 2
medication only group
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.

Other Names:
  • Zoloft
  • Lithium
Experimental: MDD Mechanism 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.

Primary Outcome Measures :
  1. Hamilton Rating Score for Depression [ Time Frame: within the first seven weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00581009

Contact: Joseph C Wu, M.D. 949-824-7867

United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Joseph C Wu, M.D.    949-824-7867   
Sub-Investigator: William E Bunney, Jr., M.D.         
Sub-Investigator: Steven Potkin, M.D.         
Sub-Investigator: Jody Rawles, M.D.         
Sub-Investigator: Charles Nguyen, M.D.         
Sub-Investigator: Marquis Vawter, Ph.D.         
Sub-Investigator: Marcel Hungs, M.D.         
University of California, San Diego Recruiting
La Jolla, California, United States, 92093 - 0603
Contact: John R Kelsoe, M.D.    858-534-5927   
Principal Investigator: John R Kelsoe, M.D.         
Sponsors and Collaborators
University of California, Irvine
University of California, San Diego
Study Chair: Barry F Chaitin, M.D. University of California, Irvine

Responsible Party: Joseph C. Wu, M. D. ,Associate Professor, Psychiatry, UCI-SOM, Clinical Director, Brain Imaging Center, University of California, Irvine Identifier: NCT00581009     History of Changes
Other Study ID Numbers: HS#2001-1616
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: November 2010

Keywords provided by University of California, Irvine:
Sleep deprivation

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Sleep Deprivation
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antidepressive Agents
Lithium Carbonate
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antimanic Agents