DepressionNCT01032434
An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia
A study testing sertraline in people with Depression, run by Guang Dong Provincial Mental Health Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study patients must fulfil all of the following criteria:
- 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
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- 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
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- 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
- An absolute neutrophil count (ANC) of 1.5 x 109/L
- Sleep disorder such as Apnea and Hyponea Syndrome, PLMS and narcolepsy
- The work time is rotate and/or often flies across the time zone
- Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs)
- Concomitant use in patients taking pimozide
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Mental Health Institute
Guangzhou, Guangdong, 510120
About this study
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.
Read more
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.
Read the detailed description
[Abstract] Purpose of the study: To evaluate the effect of sertraline on polysomnographic (PSG) variables and clinical improvement in the treatment of depressive patients with insomnia. Methods used: The study design was 8-week and open-label trial. Patients were diagnosed as major depressive disorder. Their Hamilton Rating Scale for Depression (HRSD) score was more than 18, and HRSD-sleep disturbance score was more than 3. After 7-day wash-out period and 2 nights PSG (the first night as adaptive and the second night as baseline), 31 depressive patients were administered by sertraline as 50 mg in 8 am in the 1st day. The dosage of sertraline would be titrated during the 8-week treatment, and the maximum was lower than 200 mg/day. The primary endpoints were the changes of PSG variables from baseline to the 56th Day. The secondary endpoints were the changes of subjective sleep quality and clinical performance from baseline to the 56th Day. Their sleep quality was evaluated with Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI), and their clinical performance was evaluated with HRSD and Clinical Globe Impression (CGI). Summary of results containing real data and appropriate statistical assessments: The Intent-to-Treat analysis included 31 subjects. The final dosage was titrated as 130.6±47.8 mg/day. The Rapid Eye Movement (REM) sleep latency was prolonged significantly in the 1st day and throughout 8-week treatment. The percentage of REM sleep decreased significantly in the 1st day, but increased gradually along the following treatment. AI reached the highest level in the 1st day (13.8±7.2), and decreased along the following treatment. SL decreased significantly and reached normal range (<30minutes) after the visit of 14th day. The percentage of stage 3 increased gradually, and became higher in the 14th, 28th, 56th days. HRSD score was similar between baseline and the 1st day, and became significantly lower in the 14th, 28th, and 56th day. Similar pattern was shown in CGI. Scores of HRSD-sleep disturbance, PSQI, ESS decreased gradually throughout the treatment. The sleep latency in multiple sleep latency test maintained stable throughout treatment. The reducing score rates of HRSD and CGI-GI significantly correlated with the reducing score rate of REM latency in all visits, and they also significantly correlated with sleep latency, sleep efficiency, and stage 3 in some visits. Further, significant correlation was shown between the reducing score rate of HRSD in the 56th day and the the reducing score rate of REM latency in the 1st day (r=-0.733, P=0.003). Conclusions: Sertraline was an effective antidepressant, and its effectiveness had relationship with the reduction of REM latency during the 8-week treatment. Further, the final clinical improvement could be predicted by the extent of shorten REM latency in the first night. So the suppression of REM sleep might be the key mechanism of antidepressive[1]. On the other hand, Sertraline had little alerting property without sleep disturbance in the treatment[2]. This property of sertraline must benefit the remission of depression, and the remission contributed the sleep improvement in turn. It was virtuous cycle in depressive treatment.
- Conditions
- Depression
- Being tested
- sertraline
- Keywords
- sertraline, Polysomnograph
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called zoloft
sertraline: 50-200mg/day
| Study group | Role | What they receive |
|---|---|---|
| sertraline | Experimental | sertraline: 50-200mg/day Receives: Drug: sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of sertraline on suppressing the percentage of REM sleep in depressive patients with insomnia as mono-therapy
Measured: 56 days
Secondary outcomes (2)
the effect of sertraline on sleep continuity and SWS as mono-therapy
Measured: 56 days
the correlation between the degree of REM suppression with the degree of clinical improvement in the treatment of sertraline as mono-therapy.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang Dong Provincial Mental Health Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Zhang, Guang Dong Provincial Mental Health Institute
- Investigators
- Bin Zhang, M.D&Ph.D, Principal investigator, Guang Dong Provincial Mental Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032434
- Sponsor's protocol ID
- WS 458774
- Status last verified
- Apr 2015
- First submitted
- 14 Dec 2009
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23994660
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia
- ClinicalTrials.gov ID
- NCT01032434
- Acronym / sponsor ID
- WS 458774
- Conditions
- Depression
- Keywords
- sertraline, Polysomnograph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Guang Dong Provincial Mental Health InstituteUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
[Abstract] Purpose of the study: To evaluate the effect of sertraline on polysomnographic (PSG) variables and clinical improvement in the treatment of depressive patients with insomnia. Methods used: The study design was 8-week and open-label trial. Patients were diagnosed as major depressive disorder. Their Hamilton Rating Scale for Depression (HRSD) score was more than 18, and HRSD-sleep disturbance score was more than 3. After 7-day wash-out period and 2 nights PSG (the first night as adaptive and the second night as baseline), 31 depressive patients were administered by sertraline as 50 mg in 8 am in the 1st day. The dosage of sertraline would be titrated during the 8-week treatment, and the maximum was lower than 200 mg/day. The primary endpoints were the changes of PSG variables from baseline to the 56th Day. The secondary endpoints were the changes of subjective sleep quality and clinical performance from baseline to the 56th Day. Their sleep quality was evaluated with Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI), and their clinical performance was evaluated with HRSD and Clinical Globe Impression (CGI). Summary of results containing real data and appropriate statistical assessments: The Intent-to-Treat analysis included 31 subjects. The final dosage was titrated as 130.6±47.8 mg/day. The Rapid Eye Movement (REM) sleep latency was prolonged significantly in the 1st day and throughout 8-week treatment. The percentage of REM sleep decreased significantly in the 1st day, but increased gradually along the following treatment. AI reached the highest level in the 1st day (13.8±7.2), and decreased along the following treatment. SL decreased significantly and reached normal range (<30minutes) after the visit of 14th day. The percentage of stage 3 increased gradually, and became higher in the 14th, 28th, 56th days. HRSD score was similar between baseline and the 1st day, and became significantly lower in the 14th, 28th, and 56th day. Similar pattern was shown in CGI. Scores of HRSD-sleep disturbance, PSQI, ESS decreased gradually throughout the treatment. The sleep latency in multiple sleep latency test maintained stable throughout treatment. The reducing score rates of HRSD and CGI-GI significantly correlated with the reducing score rate of REM latency in all visits, and they also significantly correlated with sleep latency, sleep efficiency, and stage 3 in some visits. Further, significant correlation was shown between the reducing score rate of HRSD in the 56th day and the the reducing score rate of REM latency in the 1st day (r=-0.733, P=0.003). Conclusions: Sertraline was an effective antidepressant, and its effectiveness had relationship with the reduction of REM latency during the 8-week treatment. Further, the final clinical improvement could be predicted by the extent of shorten REM latency in the first night. So the suppression of REM sleep might be the key mechanism of antidepressive[1]. On the other hand, Sertraline had little alerting property without sleep disturbance in the treatment[2]. This property of sertraline must benefit the remission of depression, and the remission contributed the sleep improvement in turn. It was virtuous cycle in depressive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sertraline | Experimental | Drug: sertralinesertraline: 50-200mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertralineAlso: zoloftsertraline: 50-200mg/day | Drug | sertraline |
Primary outcome
the effect of sertraline on suppressing the percentage of REM sleep in depressive patients with insomnia as mono-therapy
Time frame: 56 days
2 secondary outcomes
the effect of sertraline on sleep continuity and SWS as mono-therapy
Time frame: 56 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Derived from this study: PubMed 23994660Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Zhang, M.D&Ph.D principal investigator
Guang Dong Provincial Mental Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sertraline in people with Depression, run by Guang Dong Provincial Mental Health Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of sertraline on suppressing the percentage of REM sleep in depressive patients with insomnia as mono-therapy (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.