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Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

Sponsor
Jesper Ekelund (Other)
Overall Status
Completed
CT.gov ID
NCT00565175
Collaborator
Finland: Lilly saatio foundation (Other)
30
Enrollment
5
Locations
2
Arms
47
Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: famotidine

Drug: famotidine
Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.
Other Names:
  • Famotidin Hexal

    		•
    Placebo Comparator: Placebo

    Drug: Placebo (Microcrystallized cellulose)
    Placebo administered in identical capsules as the experimental drug.
    Other Names:
  • Microcrystallized cellulose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Scale for the Assessment of Negative Symptoms (SANS) score [5 weeks]

    Secondary Outcome Measures

    1. Positive and Negative Syndrome Scale (PANSS) score [5 weeks]

    2. Clinical Global Impression (CGI) score [5 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 HUCH Department of Psychiatry Helsinki Finland 10029
    2 Kellokosken sairaala Kellokoski Finland 04500
    3 Lohjan sairaanhoitoalue Lohja Finland 08450
    4 Vaasa Hospital District Vaasa Finland
    5 Peijaksen sairaala Vantaa Finland 01450

    Sponsors and Collaborators

    • Jesper Ekelund
    • Finland: Lilly saatio foundation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jesper Ekelund, Professor of psychiatry, University of Helsinki
    ClinicalTrials.gov Identifier:
    NCT00565175
    Other Study ID Numbers:
    • 2006-006636-22
    • 2006-006636-22
    First Posted:
    Nov 29, 2007
    Last Update Posted:
    Mar 20, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Jesper Ekelund, Professor of psychiatry, University of Helsinki
    Treatment resistant
    Chronic
    Additional relevant MeSH terms:
    Schizophrenia
    Famotidine

    Study Results

    No Results Posted as of Mar 20, 2012