An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia
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. SSRIs can suppress REM sleep and delay REM latency too, but they increase awakenings and reduce SWS at the same time. One PSG study shown sertraline minimally increases sleep efficiency and reduces nocturnal wakefulness time, which may benefit depressive patients. However, this study compared the sleep architecture before and after 12 weeks of pharmacotherapy, so the tolerance to the disturbance of sleep architecture in antidepressants appears to develop over several weeks of treatment. Sertraline has a greater potency against 5-HT reuptake as well as better selectivity for 5-HT reuptake relative to NE reuptake than any other SSRIs, and the relative selectivity of sertraline for inhabiting 5-HT reuptake relative to DA reuptake is somewhat less than of any other SSRIs. So it has chance to exhibit better effect on sleep architecture in depressive patients.
Finally, it is difficult to be determined that the unique phenomenon of sertraline is its genuine characteristics or the tolerance after 12-week treatment, so it is crucial to assess the effect of sertraline on sleep architecture in acute treatment. We hypothesized that sertraline could suppress the REM sleep, and have little damage to the sleep architecture of depressive patient.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia|
- the effect of sertraline on suppressing the percentage of REM sleep in depressive patients with insomnia as mono-therapy [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
- the effect of sertraline on sleep continuity and SWS as mono-therapy [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
- the correlation between the degree of REM suppression with the degree of clinical improvement in the treatment of sertraline as mono-therapy. [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Other Name: zoloft
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032434
|Guangdong Provincial Mental Health Institute|
|Guang Zhou, Guangdong, China, 510120|
|Principal Investigator:||Bin Zhang, M.D&Ph.D||Guang Dong Provincial Mental Health Institute|