Trial Outcomes & Findings for The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients (NCT NCT00581009)

Last Updated: 2024-10-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

49 participants

Primary outcome timeframe

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

Results posted on

2024-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Medication Only Group medication only group Medication as usual, which included 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.	Chronobiological Augmentation Group chronobiological augmentation group Chronobiological augmentation consists of sleep deprivation for one night, partial sleep phase advance for three nights, and light therapy for two hours for three days
Overall Study STARTED	17	32
Overall Study Sample Recruitment	17	32
Overall Study COMPLETED	17	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronobiological Augmentation n=32 Participants chronobiological augmentation group chronobiological augmentation: Chronobiological augmentation consists of sleep deprivation for one night, partial sleep phase advance for three nights and ight therapy for two hours for three days	Medication Only n=17 Participants medication only group medication as usual, including: 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.	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	17 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39 years STANDARD_DEVIATION 13 • n=5 Participants	40 years STANDARD_DEVIATION 14 • n=7 Participants	39.3 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	7 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	17 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

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

Population: Bipolar disorder subjects

Outcome measures

Outcome measures
Measure	Chronobiological Augmentation n=32 Participants chronobiological augmentation group 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	Medication Only n=17 Participants medication only group 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.
Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version Baseline	19 Total score on a scale Standard Deviation 6.7	18.5 Total score on a scale Standard Deviation 7.1
Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version Day 7	10.2 Total score on a scale Standard Deviation 7.3	14.4 Total score on a scale Standard Deviation 8
Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version Week 7	10.1 Total score on a scale Standard Deviation 9.6	15.2 Total score on a scale Standard Deviation 10.2

Adverse Events

Chronobiological Augmentation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Medication Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chronobiological Augmentation n=32 participants at risk chronobiological augmentation group 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	Medication Only n=17 participants at risk medication only group 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.
Psychiatric disorders brief hypomanic switch	6.2% 2/32 • Number of events 2	0.00% 0/17

Additional Information

Dr. Joseph Wu

University of California Irvine

Phone: 7142252212

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place