Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

March 19, 2012 updated by: Jesper Ekelund
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 10029
        • HUCH Department of Psychiatry
      • Kellokoski, Finland, 04500
        • Kellokosken sairaala
      • Lohja, Finland, 08450
        • Lohjan sairaanhoitoalue
      • Vaasa, Finland
        • Vaasa Hospital District
      • Vantaa, Finland, 01450
        • Peijaksen sairaala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo (Microcrystallized cellulose)
Placebo administered in identical capsules as the experimental drug.
Other Names:
  • Microcrystallized cellulose
Experimental: famotidine
Drug: famotidine
Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.
Other Names:
  • Famotidin Hexal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scale for the Assessment of Negative Symptoms (SANS) score
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Positive and Negative Syndrome Scale (PANSS) score
Time Frame: 5 weeks
5 weeks
Clinical Global Impression (CGI) score
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jesper Ekelund

Collaborators

Finland: Lilly saatio foundation

Investigators

  • Principal Investigator: Jesper Ekelund, MD-PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 28, 2007

First Submitted That Met QC Criteria

November 28, 2007

First Posted (Estimate)

November 29, 2007

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-006636-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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