Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
140 participants
INTERVENTIONAL
2014-03-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Famotidine
Famotidine 100mg x 2 orally
Famotidine
100mg x 2 p.o.
Placebo
Placebo control
Placebo
Interventions
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Famotidine
100mg x 2 p.o.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical Global Impression (CGI) severity score of at least 3.
* No changes in schizophrenia treatment within 12 weeks before study inclusion.
* Written informed consent
* The subjects must fulfil schizophrenia criteria both according to DSM- IV (295.10, .20, .30, .60, .90) (American Psychiatric association) and the Research Diagnostic Criteria for schizophrenia (RDC) \[40\]. They must also have at least mild residual symptoms (CGI 3 points). The DSM-IV diagnosis will be verified by use of the SCID-I \[41\]. The DSM-IV is clearly the most commonly used in psychiatric research, so this is important to be able to generalize the findings. However, several previous studies have used the RDC, so to be able to compare the results, we will diagnose the patients according to both systems.
* Women of child-bearing age will be included only of they use adequate contraception, or if we can otherwise verify that the subject is not pregnant (s-HCG), the possibility of pregnancy is negligible (e.g. the personnel of the housing facility reports that the person has not had sexual relationships for years) and the subject approves to remain sexually abstinent for the duration of the study.
Exclusion Criteria
* History of substance addiction or abuse within 3 months prior to enrolment.
* Individuals who are deemed at risk for aggressive behaviour or suicide
* If their laboratory tests, EKG or other clinical observation warrants exclusion, they will be excluded
* Women who are pregnant or breast-feeding subjects will not be included in the study.
* Patients with any serious unstable physical illness will also be excluded
* Patients who have been deemed to be legally incapacitated according to Finnish or Swedish law.
* Regular Uuse of H2-antagonists as prescribed by a physician.
* Known allergy to famotidine or any other component of interventional drug will be excluded.
* Ongoing treatment with clozapine and dixyrazine.
* Clinical condition "very much improved" or "much improved", assessed by CGI, during the placebo lead-in
* Renal insufficiency (P-creatinine not within normal range. Glomerular filtration rate \<30 ml/min according to the Cockcroft-Gault formula. )
* Liver insufficiency (S-ALAT elevated more than 2-fold above the laboratory specific normal range)
18 Years
65 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Region Stockholm
OTHER_GOV
City of Helsinki
OTHER
Stanley Medical Research Institute
OTHER
Ahokas foundation, Finland
UNKNOWN
Jesper Ekelund
OTHER
Responsible Party
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Jesper Ekelund
Professor
Principal Investigators
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Jesper Ekelund, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Helsinki
Locations
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Helsinki University Central Hospital Psychiatry Centre
Helsinki, , Finland
Helsinki University
Helsinki, , Finland
Social services and Healthcare, City of Helsinki
Helsinki, , Finland
Kellokoski Hospital
Hyvinkää, , Finland
Karolinska Institutet
Stockholm, , Sweden
Norra Stockholms Psykiatri, Stockholm County Council
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Viacheslav Terevnikov, MD, PhD
Role: primary
References
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Meskanen K, Ekelund H, Laitinen J, Neuvonen PJ, Haukka J, Panula P, Ekelund J. A randomized clinical trial of histamine 2 receptor antagonism in treatment-resistant schizophrenia. J Clin Psychopharmacol. 2013 Aug;33(4):472-8. doi: 10.1097/JCP.0b013e3182970490.
Other Identifiers
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2012-005513-40
Identifier Type: -
Identifier Source: org_study_id
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