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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2010 by University of California, Irvine
Sponsor:
Collaborator:
University of California, San Diego
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581009
First received: December 19, 2007
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Hamilton Rating Score for Depression [ Time Frame: within the first seven weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2001
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581009

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

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Joseph C Wu, M.D.    949-824-7867    jcwu@uci.edu   
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    jkelsoe@ucsd.edu   
Principal Investigator: John R Kelsoe, M.D.         
Sponsors and Collaborators
University of California, Irvine
University of California, San Diego
Investigators
Study Chair: Barry F Chaitin, M.D. University of California, Irvine
  More Information

No publications provided

Responsible Party: Joseph C. Wu, M. D. ,Associate Professor, Psychiatry, UCI-SOM, Clinical Director, Brain Imaging Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00581009     History of Changes
Other Study ID Numbers: HS#2001-1616
Study First Received: December 19, 2007
Last Updated: November 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Sleep deprivation
antidepressant
depression
chronobiological

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Sleep Deprivation
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antidepressive Agents
Lithium Carbonate
Sertraline
Dopamine
Lithium
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Cardiovascular Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents

ClinicalTrials.gov processed this record on August 19, 2014