The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients - Full Text View

Sponsor:	University of California, Irvine
Collaborator:	University of California, San Diego
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00581009

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Bipolar Disorder Depression Nuclear Scans

Drug Information available for: Dopamine Sertraline hydrochloride Sertraline Lithium carbonate Lithium citrate

U.S. FDA Resources

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
1: Experimental 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
2: Experimental 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.
MDD Mechanism: Experimental	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:

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:

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

Contacts and Locations

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:	University of California, Irvine ( Joseph C. Wu, M. D. ,Associate Professor, Psychiatry, UCI-SOM, Clinical Director, Brain Imaging Center )
Study ID Numbers:	HS#2001-1616
Study First Received:	December 19, 2007
Last Updated:	December 1, 2009
ClinicalTrials.gov Identifier:	NCT00581009 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Sleep deprivation
antidepressant
depression
chronobiological

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Sleep Disorders
Depressive Disorder, Major
Signs and Symptoms
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Sertraline
Antidepressive Agents
Lithium

Tranquilizing Agents
Disease
Depression
Bipolar Disorder
Nervous System Diseases
Central Nervous System Depressants
Dyssomnias
Lithium Carbonate
Enzyme Inhibitors
Antimanic Agents
Depressive Disorder
Antipsychotic Agents
Serotonin Uptake Inhibitors
Sleep Deprivation
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010