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

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Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

This study is currently recruiting participants.

Study NCT00565175. Last updated on January 3, 2008. Information provided by Helsinki University

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

Official Title ^†

Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

Brief 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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Schizophrenia

Intervention ^†

Drug: famotidine
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

January 2008

Completion Date

December 2009

Eligibility 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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Jesper Ekelund, MD-PhD

+358-50-3317987

Jesper.Ekelund@ktl.fi

Location Countries ^†

Finland

Administrative Information Fields

NCT ID ^†

NCT00565175

Organization ID

2006-006636-22

Secondary IDs ^††

EudraCT: 2006-006636-22

Study Sponsor ^†

Helsinki University

Collaborators ^††

Finland: Lilly saatio foundation

Investigators ^†

Principal Investigator:

Jesper Ekelund, MD-PhD

Helsinki University

Information Provided By

Helsinki University

Verification Date

November 2007

First Received Date ^†

November 28, 2007

Last Updated Date

January 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.