Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
|Schizophrenia||Drug: famotidine Drug: Placebo (Microcrystallized cellulose)||Phase 4|
|Study Design:||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|
- Scale for the Assessment of Negative Symptoms (SANS) score [ Time Frame: 5 weeks ]
- Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: 5 weeks ]
- Clinical Global Impression (CGI) score [ Time Frame: 5 weeks ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565175
|HUCH Department of Psychiatry|
|Helsinki, Finland, 10029|
|Kellokoski, Finland, 04500|
|Lohja, Finland, 08450|
|Vaasa Hospital District|
|Vantaa, Finland, 01450|
|Principal Investigator:||Jesper Ekelund, MD-PhD||Helsinki University Central Hospital|