Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
Information source: Helsinki University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: famotidine (Drug); Placebo (Microcrystallized cellulose) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Jesper Ekelund Official(s) and/or principal investigator(s): Jesper Ekelund, MD-PhD, Principal Investigator, Affiliation: Helsinki University Central Hospital
Summary
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.
Clinical Details
Official title: Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Scale for the Assessment of Negative Symptoms (SANS) score
Secondary outcome: Positive and Negative Syndrome Scale (PANSS) scoreClinical Global Impression (CGI) score
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of schizophrenia assessed by SCID-I (DSM-IV) as well as RDC-criteria
- Patient record mention of schizophrenia (ICD-10) at least 5 years previously
- Disability pension due to psychiatric disorder
- At least 3 points on the CGI scale
Exclusion Criteria:
- Epilepsy or a history of unclear seizures
- Stroke
- Parkinson's disease
- AIDS
- Substance addiction or abuse within 3 months prior to enrolment.
- Individuals who are deemed at risk for aggressive behavior or suicide by their
clinician
- Pregnant and breast-feeding subjects
- Serious unstable physical illness
- Persons who have been deemed legally incapacitated according to Finnish law (Laki
holhoustoimesta 1. 4.1999/442, 3. luku, 18 §)
- Individuals who use H2-antagonists as prescribed by a physician
- Known allergy to famotidine or any other component of the Pepcidin® 40 mg tablet
- Glomerular Filtration Rate (GFR) according to the Cockcroft-Gault formula < 30 ml/min
Locations and Contacts
HUCH Department of Psychiatry, Helsinki 10029, Finland
Kellokosken sairaala, Kellokoski 04500, Finland
Lohjan sairaanhoitoalue, Lohja 08450, Finland
Vaasa Hospital District, Vaasa, Finland
Peijaksen sairaala, Vantaa 01450, Finland
Additional Information
Starting date: January 2008
Last updated: March 19, 2012
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