An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia

NCT01032434 | Completed

• 1 other identifier: WS 458774
• Study Type: interventional
• Target: 31
• 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. 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.

Conditions

Depression

Keywords

sertraline; Polysomnograph

Outcome Measures

Primary Outcomes (1)

• the effect of sertraline on suppressing the percentage of REM sleep in depressive patients with insomnia as mono-therapy

  56 days

Secondary Outcomes (2)

• the effect of sertraline on sleep continuity and SWS as mono-therapy

  56 days

• the correlation between the degree of REM suppression with the degree of clinical improvement in the treatment of sertraline as mono-therapy.

  56 days

Study Arms (1)

sertraline

EXPERIMENTAL

sertraline: 50-200mg/day

Drug: sertraline

Interventions

sertraline DRUG

sertraline: 50-200mg/day

Also known as: zoloft

sertraline

Eligibility Criteria

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

You may qualify if:

• Provision of written informed consent by patient or his/her legal guardian
• Hospitalised for a diagnosis of major depressive disorder by DSM-IV (296.2X, 296.3X)
• HRSD score\>18
• Total score of sleep disturbance factor in HRSD (items 4, 5, and 6; score range, 0-6)\>3
• Females or males, and aged 18 to 65 years
• Able to understand and comply with the requirements of the study

You may not qualify if:

• Pregnancy or lactation
• Any DSM-IV Axis I disorder, except for major depressive disorder
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Known intolerance or lack of response to sertraline, as judged by the investigator
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
• Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
• Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
• Organic change was founded by brain CT
• Involvement in the planning and conduct of the study
• Previous enrolment or randomisation of treatment in the present study
• Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

Sponsors & Collaborators

• Guang Dong Provincial Mental Health Institute: lead

Study Sites (1)

Guangdong Provincial Mental Health Institute

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• Zhang B, Hao Y, Jia F, Tang Y, Li X, Liu W, Arnulf I. Sertraline and rapid eye movement sleep without atonia: an 8-week, open-label study of depressed patients. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Dec 2;47:85-92. doi: 10.1016/j.pnpbp.2013.08.010. Epub 2013 Aug 29.

  PMID: 23994660 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Bin Zhang, M.D&Ph.D

  Guang Dong Provincial Mental Health Institute

  PRINCIPAL INVESTIGATOR

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: Sleep Centre

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 4, 2015

Record last verified: 2015-04

Locations

CN (1)