The effect of agomelatine on sleep disturbance, depression and anxiety in patients with systemic lupus erythematosus, a randomized, double-blinded, placebo-controlled trial
- Conditions
- SLEsleep disturbanceslesleep disturbance
- Registration Number
- TCTR20171010002
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 72
1.Age between 18-75 years
2.Diagnosed with SLE according to ACR1997 criteria
3.Pittsburgh Sleep Quality Index (PSQI) score of more than 5 on screening day
4.No sign of major depression inventory
5.Able to communicate
1.Known allergic reaction to agomelatine
2.Diagnosed with SLE mixed with other connective tissue disease
3.Treatment with medications which have drug-drug interaction to agomelatine (via CYP1A2) such as atazanavir, fluvoxamine, cimetidine, ciprofloxacin, estrogen therapy, thiabendazole, zileuton, primidone, carbamazepine and rifampicin
(DMPA injection or condom use together with date counting will be suggested for contraception)
4.Ongoing or previous medically treated depression or bipolar disorder
5.Active liver disease (elevation of aminotransferases of more than 3 times of upper normal limit)
6.Impaired Kidney function (Creatinine >2)
7.Known medically treated sleep disorder (receiving hypnotic medication)
8.Shift work/night work
9.Daily intake of more than 5 units of alcohol
10.Predicted poor compliance
11.Pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate of sleep disturbance 12 weeks Pittsburgh sleep quality index
- Secondary Outcome Measures
Name Time Method response rate of anxiety 12 weeks HAM-A score,response rate of depression 12 weeks HAM-D score,response rate of fatigue 12 weeks FACIT score,disease activity between 12 weeks SLEDAI-2K