Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00565175
• Date of registration: 28/11/2007
• Prospective Registration: Yes
• Primary sponsor: Jesper Ekelund
• Public title: Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
• Scientific title: Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
• Date of first enrolment: January 2008
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00565175
• 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
• Phase: Phase 4

Countries of recruitment

Finland

Contacts

• Name: Jesper Ekelund, MD-PhD
• Affiliation: Helsinki University Central Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: famotidine

Drug: Placebo (Microcrystallized cellulose)

Primary Outcome(s)

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

Secondary Outcome(s)

Clinical Global Impression (CGI) score [Time Frame: 5 weeks]

Positive and Negative Syndrome Scale (PANSS) score [Time Frame: 5 weeks]

Secondary ID(s)

2006-006636-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Finland: Lilly saatio foundation