Schizophrenia Clinical Trial
Official title:
Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia
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.
Schizophrenia is a mental dysfunction of thought, perception and behaviour which can be
attributed to complex and dynamically interacting perturbations in multiple neurochemical
systems. Along with these cardinal features of schizophrenia, sleep disorders and disturbed
circadian rhythm are commonly encountered among patients. Markedly decreased sleep
efficiency, delayed sleep onset and frequent awakenings are most common observations.
Endogenous melatonin is a dependable biomarker of circadian rhythmicity and, it has already
been found that the nocturnal rise of endogenous melatonin is blunted leading to circadian
dysrhythmia in schizophrenia.
The antipsychotics prescribed for the condition though cause improvement in the cardinal
symptoms of the disease but have no significant effect on melatonin levels. The blunted peak
of night time melatonin secretion are not restored or even decreased even after several
months therapy with antipsychotics. In this clinical scenario, add-on therapy with sedative/
hypnotics along with antipsychotics is mandate for a prescription. Previous studies revealed
that add-on therapy with benzodiazepines can worsen the already existing derangement in
circadian rhythm by decreasing secretion of nocturnal melatonin. A long term add on therapy
with benzodiazepines in patients on antipsychotics has been found to have an increased risk
of death.
Addition of melatonin to the pharmacotherapy of schizophrenia elevates mood and daytime
functioning in addition to improved sleep in schizophrenia patients. Melatonin, apart from
being a hypnotic and circadian rhythm restoring compound, also possess neuroprotective,
anti-neuroinflammatory and antioxidant properties. The rate limiting step of melatonin
biosynthetic pathway is the alkylation of serotonin to N- acetyl serotonin, catalyzed by
enzyme AANAT (aryl-alkylamine- N-acetyl-transferase). Study of AANAT enzyme and its
modulation to achieve normal rhythmical secretion of melatonin can also be a potential target
for resynchronising the circadian rhythm.
Ramelteon is a melatonin receptor agonist approved for treatment of insomnia by the USFDA. It
exerts its action by acting on MT1 and MT2 receptors at suprachiasmatic nucleus. The long
term safety of ramelteon has been evaluated by several workers and found no significant
adverse effects like abuse liability, rebound insomnia and cognitive impairment. In contrast
to melatonin, it shows higher-binding affinity for MT1 and MT2 receptors, more lipophilic and
has a longer half-life(t1/2 of melatonin is 20-50 min whereas that of ramelteon is 1-2.6 hrs
and that of its active melabolite M-II is 2-5 hrs). In addition, ramelteon has been already
evaluated as a potential adjunctive treatment for learning and memory deficits in
schizophrenia.
The sleep and circadian rhythm disorders in schizophrenia have so far been given very less
importance by researchers and there are limited studies targeting or modulating the melatonin
pathway. Therefore, 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.
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