The purpose of the study is to investigate whether blockade of the histamine H2 receptors in the brain will have any beneficial effect on the symptoms of subjects with schizophrenia.
Histamine functions as a neurotransmitter in the brain. It has an important role as modulator of the release of other neurotransmitters, including dopamine. The histamine receptors are widely expressed in the brain, H1 and H2 receptors are post-synaptic, H3 a pre-synaptic autoreceptor. There is an abundance of neurobiologic data from animal and human studies supporting the role of histamine in the pathogenesis and treatment of psychoses. In 1990 a case report of a treatment resistant subject with schizophrenia whos symptoms improved markedly when he was prescribed a H2 antagonist because of peptic ulcer. Later, a open-label trial including 18 patients has been performed, reporting significant symptom reduction, especially on negative symptoms. Also the subjective comments both by the subjects and the investigators in that study were optimistic and suggested an effect primarily on negative symptoms. The present study will be the first double-blind, randomized, placebo controlled, parallel group study of the subject matter. The study focuses on treatment resistant schizophrenia cases in the stable phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.
Placebo administered in identical capsules as the experimental drug.
HUCH Department of Psychiatry
Helsinki, Finland
Kellokosken sairaala
Kellokoski, Finland
Lohjan sairaanhoitoalue
Lohja, Finland
Vaasa Hospital District
Vaasa, Finland
Peijaksen sairaala
Scale for the Assessment of Negative Symptoms (SANS) score
Time frame: 5 weeks
Positive and Negative Syndrome Scale (PANSS) score
Time frame: 5 weeks
Clinical Global Impression (CGI) score
Time frame: 5 weeks
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Vantaa, Finland