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

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	Phase IV

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Cellulose Cellulose sodium phosphate Phosphocellulose Famotidine Histamine Histamine dihydrochloride Histamine phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

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 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: famotidine capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks
2: Placebo Comparator	Drug: Placebo Placebo administered in identical capsules as the experimental drug.

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 <30ml/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
	Lohjan sairaanhoitoalue	Not yet 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
	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
	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
	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

Sponsors and Collaborators

Helsinki University

Finland: Lilly saatio foundation

Investigators


Principal Investigator:	Jesper Ekelund, MD-PhD	Helsinki University

More Information

Responsible Party:	Helsinki University Central Hospital ( Jesper Ekelund, MD-PhD )
Study ID Numbers:	2006-006636-22, EudraCT: 2006-006636-22
First Received:	November 28, 2007
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00565175
Health Authority:	Finland: National Agency for Medicines; Finland: Ethics Committee

Keywords provided by Helsinki University:

Treatment resistant

Chronic

Study placed in the following topic categories:

Schizophrenia

Famotidine

Mental Disorders

Histamine phosphate

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Histamine Antagonists

Therapeutic Uses

Physiological Effects of Drugs

Anti-Ulcer Agents

Gastrointestinal Agents

Histamine Agents

Histamine H2 Antagonists

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008

Sponsors and Collaborators:	Helsinki University Finland: Lilly saatio foundation
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00565175