SLE sleep disturbance sle sleep disturbance
Conditions
Interventions
agometaline 12.5 or 25 mg taken daily before bedtime for 12 weeks,placebo which looks identical to agomelatine
Experimental Drug,Placebo Comparator No treatment
agomelatine,placebo
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate of sleep disturbance 12 weeks Pittsburgh sleep quality index | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
thailand
Contacts
Public Contactsalin kiratikanon
Faculty of medicine, Chiang Mai university
Outcome results
None listed