Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jesper Ekelund
• Collaborator: Finland: Lilly saatio foundation
• Treatments: Famotidine; Histamine; Histamine phosphate

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