DepressionNCT02442713
The Effect of Fluvoxamine on Polysonogram in Depressed Patients With Insomnia
A study testing fluvoxamine 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?
- fluvoxamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2016
- 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:
- 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
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- 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
Show all 9Show fewer
- Pregnancy or lactation
- Substance or alcohol dependence or any drug abuse.
- Other conditions at Investigator's discretion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Mental Health Institute
Guangzhou, Guangdong, 510120
Bin Zhang, M.D&Ph.D, 8620-81888553, zhang73bin@hotmail.com
Bin Zhang, M.D&Ph.D
About this study
Official title: A Baseline Controlled Study With Fluvoxamine to Evaluate the Effect on Polysonogram in Depressed 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.
Read more
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.
Read the detailed description
This study is aimed to evaluate the effect of fluvoxamine on polysomnographic (PSG) variables and clinical improvement in the treatment of depressive patients with insomnia.
This is an 8-week open-label study. All patients are required to meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) [48 criteria for MDD, single or recurrent type, with moderate-to-high level of illness severity, as evidenced by a 17-item Hamilton Rating Scale for Depression (HRSD) score >17 [49, 50]. Furthermore, these depressed patients should be suffering insomnia, which was determined by the total score of sleep disturbance factor in HRSD >3 (items 4, 5, and 6; score range, 0-6).
Before any procedure of the study, the patient would be explained in detail about the potential risk and benefit in this study with a signed informed consent form (ICF). Patients can discontinue the study at any time after informed consent. Also, this study should be approved by Independent Ethics Committee (IEC) of Guang Dong Mental Health Center and compliance with the content of the declaration of Helsinki.
After 7-day wash-out period and 2 nights PSG (the first night as adaptive and the second night as baseline), 30 depressive patients were administered by fluvoxamine as 50 mg/day in the 1st day. The dosage of fluvoxamine would be titrated during the 8-week treatment, and the maximum was lower than 300 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).
- Conditions
- Depression
- Being tested
- fluvoxamine
- Keywords
- Polysomnograph, fluvoxamine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluvoxamineDrug
Also called Luvox
fluvoxamine: 50-300mg/day
| Study group | Role | What they receive |
|---|---|---|
| fluvoxamine | Experimental | fluvoxamine: 50-300mg/day Receives: Drug: fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of sleep during Fluvoxamine treatment
by comparing the percentages of Rapid Eye Movement (REM) on the 1st, 14th, 28th and 56th day.
Measured: 56 days
Secondary outcomes (3)
The change of Slow Wave sleep (SWS) during Fluvoxamine treatment
by comparing the percentages of Slow Wave sleep (SWS) on the 1st, 14th, 28th and 56th day.
Measured: 56 days
The change of sleep efficiency during Fluvoxamine treatment
by comparing the sleep efficiency on the 1st, 14th, 28th and 56th day.
Measured: 56 days
Clinical improvement during Fluvoxamine treatment
by comparing scores of Hamilton Rating Scale for Depression (HRSD) on the 1st, 14th, 28th and 56th day.
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 posted13 May 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
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
- 30 participants (estimated)
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
- 86-20-81888553 Zhang, M.D&Ph.D, Principal investigator, Guang Dong Provincial Mental Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442713
- Sponsor's protocol ID
- FLUVD002
- Status last verified
- May 2015
- First submitted
- 28 Apr 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31807102
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Baseline Controlled Study With Fluvoxamine to Evaluate the Effect on Polysonogram in Depressed Patients With Insomnia
- ClinicalTrials.gov ID
- NCT02442713
- Acronym / sponsor ID
- FLUVD002
- Conditions
- Depression
- Keywords
- Polysomnograph, fluvoxamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guang Dong Provincial Mental Health InstituteUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 May 2015 (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. 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.
Detailed description
This study is aimed to evaluate the effect of fluvoxamine on polysomnographic (PSG) variables and clinical improvement in the treatment of depressive patients with insomnia.
This is an 8-week open-label study. All patients are required to meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) [48 criteria for MDD, single or recurrent type, with moderate-to-high level of illness severity, as evidenced by a 17-item Hamilton Rating Scale for Depression (HRSD) score >17 [49, 50]. Furthermore, these depressed patients should be suffering insomnia, which was determined by the total score of sleep disturbance factor in HRSD >3 (items 4, 5, and 6; score range, 0-6).
Before any procedure of the study, the patient would be explained in detail about the potential risk and benefit in this study with a signed informed consent form (ICF). Patients can discontinue the study at any time after informed consent. Also, this study should be approved by Independent Ethics Committee (IEC) of Guang Dong Mental Health Center and compliance with the content of the declaration of Helsinki.
After 7-day wash-out period and 2 nights PSG (the first night as adaptive and the second night as baseline), 30 depressive patients were administered by fluvoxamine as 50 mg/day in the 1st day. The dosage of fluvoxamine would be titrated during the 8-week treatment, and the maximum was lower than 300 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluvoxamine | Experimental | Drug: fluvoxaminefluvoxamine: 50-300mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| fluvoxamineAlso: Luvoxfluvoxamine: 50-300mg/day | Drug | fluvoxamine |
Primary outcome
The change of sleep during Fluvoxamine treatment
Time frame: 56 days
by comparing the percentages of Rapid Eye Movement (REM) on the 1st, 14th, 28th and 56th day.
3 secondary outcomes
The change of Slow Wave sleep (SWS) during Fluvoxamine treatment
Time frame: 56 days
The change of sleep efficiency during Fluvoxamine treatment
Time frame: 56 days
Clinical improvement during Fluvoxamine treatment
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Derived from this study: PubMed 31807102Hao 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.
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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.
86-20-81888553 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 fluvoxamine 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Zhang, M.D&Ph.D (86-20-81888553, zhang73bin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of sleep during Fluvoxamine treatment (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 NCT02442713, 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 13 May 2015; AzTrials last refreshed its copy on 7 Nov 2026.