Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Finland: Lilly saatio foundation
Information provided by (Responsible Party):
Jesper Ekelund, Helsinki University
ClinicalTrials.gov Identifier:
NCT00565175
First received: November 28, 2007
Last updated: March 19, 2012
Last verified: March 2012
  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 (Microcrystallized cellulose)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

Resource links provided by NLM:


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 ]

Enrollment: 30
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 < 30 ml/min
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565175

Locations
Finland
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
Investigators
Principal Investigator: Jesper Ekelund, MD-PhD Helsinki University Central Hospital
  More Information

No publications provided by Helsinki University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesper Ekelund, Professor of psychiatry, Helsinki University
ClinicalTrials.gov Identifier: NCT00565175     History of Changes
Other Study ID Numbers: 2006-006636-22, 2006-006636-22
Study First Received: November 28, 2007
Last Updated: March 19, 2012
Health Authority: Finland: Finnish Medicines Agency
Finland: Ethics Committee

Keywords provided by Helsinki University:
Treatment resistant
Chronic

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Famotidine
Histamine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agonists

ClinicalTrials.gov processed this record on July 28, 2014