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

Primary Purpose

Major Depressive Disorder, Bipolar Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
chronobiological augmentation
sertraline, lithium
one night of sleep deprivation and two FDG PET scans
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Sleep deprivation, antidepressant, depression, chronobiological

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Irvine
  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

MDD Mechanism

Arm Description

chronobiological augmentation group

medication only group

Outcomes

Primary Outcome Measures

Hamilton Rating Score for Depression

Secondary Outcome Measures

Full Information

First Posted
December 19, 2007
Last Updated
January 22, 2021
Sponsor
University of California, Irvine
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00581009
Brief Title
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
Official Title
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2001 (Actual)
Primary Completion Date
December 9, 2011 (Actual)
Study Completion Date
December 9, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Disorder
Keywords
Sleep deprivation, antidepressant, depression, chronobiological

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
chronobiological augmentation group
Arm Title
2
Arm Type
Experimental
Arm Description
medication only group
Arm Title
MDD Mechanism
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
chronobiological augmentation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
sertraline, lithium
Other Intervention Name(s)
Zoloft, Lithium
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
one night of sleep deprivation and two FDG PET scans
Intervention Description
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 Measure Information:
Title
Hamilton Rating Score for Depression
Time Frame
within the first seven weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry F Chaitin, M.D.
Organizational Affiliation
University of California, Irvine
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093 - 0603
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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