The Effect of Fluvoxamine on Polysonogram in Depressed Patients With Insomnia

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang Dong Provincial Mental Health Institute
• Treatments: Fluvoxamine

Criteria

Inclusion Criteria:

For inclusion in the study patients must fulfil all of the following criteria:

1. Male or female, ≥18 years and ≤65 years old

2. 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)

3. Patients who are able to understand and comply with the requirements of the study

4. Provision of written informed consent

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

1. Any contraindication or caution of fluvoxamine according to Chinese label

2. Any DSM-IV Axis I disorder, except for major depressive disorder

3. Being currently treated or having been treated with fluvoxamine or other antidepressants within 4 weeks prior to entering the study

4. Participation to this study or another trial within 4 weeks prior to entering the study

5. Other sleeping disorder such as apnoea, Periodic Leg Movement in Sleep and narcolepsy

6. Pregnancy or lactation

7. Substance or alcohol dependence or any drug abuse.

8. Other conditions at Investigator's discretion