Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565175
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : March 20, 2012
Finland: Lilly saatio foundation
Information provided by (Responsible Party):
Jesper Ekelund, Helsinki University

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
Schizophrenia Drug: famotidine Drug: Placebo (Microcrystallized cellulose) 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 Type : Interventional  (Clinical Trial)
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 : January 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Scale for the Assessment of Negative Symptoms (SANS) score [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: 5 weeks ]
  2. Clinical Global Impression (CGI) score [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00565175

HUCH Department of Psychiatry
Helsinki, Finland, 10029
Kellokosken sairaala
Kellokoski, Finland, 04500
Lohjan sairaanhoitoalue
Lohja, Finland, 08450
Vaasa Hospital District
Vaasa, Finland
Peijaksen sairaala
Vantaa, Finland, 01450
Sponsors and Collaborators
Jesper Ekelund
Finland: Lilly saatio foundation
Principal Investigator: Jesper Ekelund, MD-PhD Helsinki University Central Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jesper Ekelund, Professor of psychiatry, Helsinki University Identifier: NCT00565175     History of Changes
Other Study ID Numbers: 2006-006636-22
2006-006636-22 ( EudraCT Number )
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by Jesper Ekelund, Helsinki University:
Treatment resistant

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists