The Effect of Fluvoxamine on Polysonogram in Depressed Patients With Insomnia

NCT02442713 | Unknown

• 1 other identifier: FLUVD002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings: (1) impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye movement (REM) sleep. The first two patterns are common in other psychiatric disorders, while the REM pattern is very characteristic in depression, so the phase-advance theory was accepted by most of psychiatrists. Many researchers have focused on the biological rhythm to investigate the etiological and pathophysiology of depression, and they think depression can be cured if its sleep abnormality is ameliorated. It is well known that most of antidepressants treat depression through 5-hydroxytryptamine (5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can ameliorate the sleep architecture abnormality in depression by producing rapid suppression of REM sleep. Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for serotonin receptors. On the other hand, it is known that, although all of SSRIs mainly increase the extracellular serotonin level by inhibiting serotonin transport in the presynaptic neuron, each SSRI has its unique pharmacological characteristics. For example, it was reported by accumulating researches that the serum melatonin level increased markedly after ingestion of fluvoxamine. The mechanism behind this effect is unknown, but one possibility is increased melatonin synthesis, caused by effects on serotonin, which is a melatonin precursor. Another possibility is that fluvoxamine inhibits the metabolism of melatonin in the liver. Thus, the property of fluvoxamine to increase serum melatonin level, or even recover the circadian rhythm of melatonin in depressed patients, might improve the clinical outcome by improving the sleep quality and quantity. By now, the changes of sleep architecture in fluvoxamine treatment were assessed by only three clinical trials, and their results were contradictive. This discrepancy might be due to the small sample size and different study design, such as clinical trial duration. Moreover, two of three researches applied home-based PSG assessment, which might have distorted the results of sleep architecture to some extent. Thus, the effects of fluvoxamine on sleep architecture need to be clarified by more clinical trials with standard PSG assessment.

Conditions

Depression

Keywords

Polysomnograph; fluvoxamine

Outcome Measures

Primary Outcomes (1)

• The change of sleep during Fluvoxamine treatment

  by comparing the percentages of Rapid Eye Movement (REM) on the 1st, 14th, 28th and 56th day.

  56 days

Secondary Outcomes (3)

• The change of Slow Wave sleep (SWS) during Fluvoxamine treatment

  56 days

• The change of sleep efficiency during Fluvoxamine treatment

  56 days

• Clinical improvement during Fluvoxamine treatment

  56 days

Study Arms (1)

fluvoxamine

EXPERIMENTAL

fluvoxamine: 50-300mg/day

Drug: fluvoxamine

Interventions

fluvoxamine DRUG

fluvoxamine: 50-300mg/day

Also known as: Luvox

fluvoxamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥18 years and ≤65 years old
• Major depressive disorder patients with insomnia (diagnosed with DSM-IV, HRSD total score \>17 and total score of sleep disturbance factor in HRSD (items 4, 5, and 6; score range, 0-6)\>3)
• Patients who are able to understand and comply with the requirements of the study
• Provision of written informed consent

You may not qualify if:

• Any contraindication or caution of fluvoxamine according to Chinese label
• Any DSM-IV Axis I disorder, except for major depressive disorder
• Being currently treated or having been treated with fluvoxamine or other antidepressants within 4 weeks prior to entering the study
• Participation to this study or another trial within 4 weeks prior to entering the study
• Other sleeping disorder such as apnoea, Periodic Leg Movement in Sleep and narcolepsy
• Pregnancy or lactation
• Substance or alcohol dependence or any drug abuse.
• Other conditions at Investigator's discretion

Sponsors & Collaborators

• Guang Dong Provincial Mental Health Institute: lead

Study Sites (1)

Guangdong Provincial Mental Health Institute

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• Hao Y, Hu Y, Wang H, Paudel D, Xu Y, Zhang B. The Effect Of Fluvoxamine On Sleep Architecture Of Depressed Patients With Insomnia: An 8-Week, Open-Label, Baseline-Controlled Study. Nat Sci Sleep. 2019 Nov 4;11:291-300. doi: 10.2147/NSS.S220947. eCollection 2019.

  PMID: 31807102 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Officials

• 86-20-81888553 Zhang, M.D&Ph.D

  Guang Dong Provincial Mental Health Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Zhang, M.D&Ph.D

CONTACT

86-20-81888553; zhang73bin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 13, 2015
• Study Start: November 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

CN (1)