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

NCT00581009 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20011616
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder; Bipolar Disorder

Keywords

Sleep deprivation; antidepressant; depression; chronobiological

Outcome Measures

Primary Outcomes (1)

• Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version

  Difference in HRSD between the chronobiological augmentation therapy and medication only groups across the first 7 days, and up to 7 weeks of treatment. The 21-item HRSD has a range of 0 to 66, with a higher score indicating more severe depression.

  within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy

Study Arms (3)

Chronobiological augmentation

EXPERIMENTAL

chronobiological augmentation group

Other: chronobiological augmentation

Medication only

EXPERIMENTAL

medication only group

Drug: sertraline, lithium

MDD Mechanism

EXPERIMENTAL

Radiation: one night of sleep deprivation and two FDG PET scans

Interventions

chronobiological augmentation OTHER

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

Chronobiological augmentation

sertraline, lithium DRUG

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.

Also known as: Zoloft, Lithium

Medication only

one night of sleep deprivation and two FDG PET scans RADIATION

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.

MDD Mechanism

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• University of California, San Diego: collaborator

Study Sites (2)

University of California, Irvine

Irvine, California, 92697, United States

Location

University of California, San Diego

La Jolla, California, 92093 - 0603, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Sleep Deprivation; Depression

Interventions

Sertraline; Lithium

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Results Point of Contact

• Title: Dr. Joseph Wu
• Organization: University of California Irvine

jcwu@uci.edu

7142252212

Study Officials

• Barry F Chaitin, M.D.

  University of California, Irvine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry & Human Behavior

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 27, 2007
• Study Start: May 30, 2001
• Primary Completion: December 9, 2011
• Study Completion: December 9, 2011
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Locations

US (2)