Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia - Full Text View

Sponsor:	Helsinki University
Collaborator:	Finland: Lilly saatio foundation
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00565175

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: famotidine Drug: Placebo (Microcrystallized cellulose)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride Cellulose sodium phosphate Famotidine Cellulose Phosphocellulose

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:

Scale for the Assessment of Negative Symptoms (SANS) score [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression (CGI) score [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: famotidine	Drug: famotidine Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks. Other Name: Famotidin Hexal
Placebo Comparator: Placebo	Drug: Placebo (Microcrystallized cellulose) Placebo administered in identical capsules as the experimental drug. Other Name: Microcrystallized cellulose

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565175

Contacts

Contact: Jesper Ekelund, MD-PhD

+358-50-3317987

Jesper.Ekelund@ktl.fi

Locations

Finland
HUCH Department of Psychiatry	Recruiting
Helsinki, Finland, 10029
Contact: Jesper Ekelund, MD-PhD +358-9-4711 Jesper.Ekelund@hus.fi
Principal Investigator: Jesper Ekelund, MD-PhD
Kellokosken sairaala	Recruiting
Kellokoski, Finland, 04500
Contact: Grigori Joffe, MD-PhD +358-9-2716 3220 Grigori.Joffe@hus.fi
Principal Investigator: Grigori Joffe, MD-PhD
Lohjan sairaanhoitoalue	Recruiting
Lohja, Finland, 08450
Contact: Jarmo Laitinen, MD +358-19-3801 700 Jarmo.Laitinen@hus.fi
Sub-Investigator: Hannu Saloheimo, MD
Principal Investigator: Jarmo Laitinen, MD
Vaasa Hospital District	Recruiting
Vaasa, Finland
Contact: Jesper Ekelund, MD-PhD +358-50-3317987 Jesper.Ekelund@hus.fi
Peijaksen sairaala	Not yet recruiting
Vantaa, Finland, 01450
Contact: Yrjo Lahteenlahti, MD +358-9-471 66530 Yrjo.Lahteenlahti@hus.fi
Principal Investigator: Yrjo Lahteenlahti, MD

Sponsors and Collaborators

Helsinki University

Finland: Lilly saatio foundation

Investigators

Principal Investigator:

Jesper Ekelund, MD-PhD

Helsinki University Central Hospital

More Information

No publications provided

Responsible Party:	Jesper Ekelund, MD-PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:	NCT00565175 History of Changes
Other Study ID Numbers:	2006-006636-22, 2006-006636-22
Study First Received:	November 28, 2007
Last Updated:	May 27, 2010
Health Authority:	Finland: Finnish Medicines Agency; Finland: Ethics Committee

Keywords provided by Helsinki University:

Treatment resistant
Chronic

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Famotidine
Histamine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agonists

ClinicalTrials.gov processed this record on February 12, 2012