Schizophrenia Clinical Trial
Official title:
Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia
Verified date | May 2019 |
Source | All India Institute of Medical Sciences, Bhubaneswar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed study has been planned to evaluate the effect of add-on ramelteon on sleep pattern/quality and circadian rhythm disruption in patients with schizophrenia.
Status | Completed |
Enrollment | 120 |
Est. completion date | August 31, 2018 |
Est. primary completion date | June 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - All adult patients of either sex with age range 18-65 years with the clinical diagnosis of schizophrenia. (DSM-V) - Treatment naïve patients or patients who had not taken any treatment for at least 4 weeks before inclusion. - Legal guardian of patients consenting to participate in the study by signing the informed consent form. Exclusion Criteria: - Schizoaffective disorder or schizophrenia with somatoform disorders. - Highly agitated patients who need immediate treatment. - Patients who are already under treatment for the presenting conditions. - Patients with comorbid substance abuse or history of organicity - Patients with known history of dementia, obstructive sleep apnoea syndrome, diabetes mellitus. - Pregnant and nursing women. - History of allergy or hypersensitivity to ramelteon. - Legal guardian of patients not willing to participate in the study. |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences (AIIMS) | Bhubaneswar | Odisha |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, Bhubaneswar |
India,
Afonso P, Figueira ML, Paiva T. Sleep-promoting action of the endogenous melatonin in schizophrenia compared to healthy controls. Int J Psychiatry Clin Pract. 2011 Nov;15(4):311-5. doi: 10.3109/13651501.2011.605954. Epub 2011 Aug 28. — View Citation
Baandrup L, Fagerlund B, Jennum P, Lublin H, Hansen JL, Winkel P, Gluud C, Oranje B, Glenthoj BY. Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial p — View Citation
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. — View Citation
Cohrs S, Pohlmann K, Guan Z, Jordan W, Meier A, Huether G, Rüther E, Rodenbeck A. Quetiapine reduces nocturnal urinary cortisol excretion in healthy subjects. Psychopharmacology (Berl). 2004 Jul;174(3):414-20. Epub 2004 Jan 20. — View Citation
Cohrs S. Sleep disturbances in patients with schizophrenia : impact and effect of antipsychotics. CNS Drugs. 2008;22(11):939-62. Review. — View Citation
Hajak G, Rodenbeck A, Bandelow B, Friedrichs S, Huether G, Rüther E. Nocturnal plasma melatonin levels after flunitrazepam administration in healthy subjects. Eur Neuropsychopharmacol. 1996 May;6(2):149-53. — View Citation
Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006 Oct;63(10):1149-57. — View Citation
Kabuto M, Namura I, Saitoh Y. Nocturnal enhancement of plasma melatonin could be suppressed by benzodiazepines in humans. Endocrinol Jpn. 1986 Jun;33(3):405-14. — View Citation
Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. — View Citation
Lavie P. Melatonin: role in gating nocturnal rise in sleep propensity. J Biol Rhythms. 1997 Dec;12(6):657-65. Review. — View Citation
Mann K, Rossbach W, Müller MJ, Müller-Siecheneder F, Pott T, Linde I, Dittmann RW, Hiemke C. Nocturnal hormone profiles in patients with schizophrenia treated with olanzapine. Psychoneuroendocrinology. 2006 Feb;31(2):256-64. Epub 2005 Sep 26. — View Citation
Miyamoto M. Pharmacology of ramelteon, a selective MT1/MT2 receptor agonist: a novel therapeutic drug for sleep disorders. CNS Neurosci Ther. 2009 Winter;15(1):32-51. doi: 10.1111/j.1755-5949.2008.00066.x. Review. — View Citation
Monteleone P, Natale M, La Rocca A, Maj M. Decreased nocturnal secretion of melatonin in drug-free schizophrenics: no change after subchronic treatment with antipsychotics. Neuropsychobiology. 1997;36(4):159-63. — View Citation
Robinson S, Rosca P, Durst R, Shai U, Ghinea C, Schmidt U, Nir I. Serum melatonin levels in schizophrenic and schizoaffective hospitalized patients. Acta Psychiatr Scand. 1991 Sep;84(3):221-4. — View Citation
Spadoni G, Bedini A, Lucarini S, Mor M, Rivara S. Pharmacokinetic and pharmacodynamic evaluation of ramelteon : an insomnia therapy. Expert Opin Drug Metab Toxicol. 2015 Jul;11(7):1145-56. doi: 10.1517/17425255.2015.1045487. Epub 2015 May 8. Review. — View Citation
Suresh Kumar PN, Andrade C, Bhakta SG, Singh NM. Melatonin in schizophrenic outpatients with insomnia: a double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Feb;68(2):237-41. — View Citation
Wehr TA, Aeschbach D, Duncan WC Jr. Evidence for a biological dawn and dusk in the human circadian timing system. J Physiol. 2001 Sep 15;535(Pt 3):937-51. — View Citation
Wulff K, Dijk DJ, Middleton B, Foster RG, Joyce EM. Sleep and circadian rhythm disruption in schizophrenia. Br J Psychiatry. 2012 Apr;200(4):308-16. doi: 10.1192/bjp.bp.111.096321. Epub 2011 Dec 22. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum melatonin over 4 weeks from baseline | ELISA | Baseline and 4 weeks | |
Secondary | Change in quality of sleep over 4 weeks from baseline | Pittsburgh Sleep Quality Index (PSQI) scoring | Baseline and 4 weeks | |
Secondary | Change in urinary melatonin(6MTs) over 4 weeks from baseline | HPLC | Baseline and 4 weeks | |
Secondary | Change in serum AANAT enzyme over 4 weeks from baseline | ELISA | Baseline and 4 weeks | |
Secondary | Change in severity of symptoms of schizophrenia over 4 weeks from baseline | PANSS Scoring | Baseline and 4 weeks |
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