|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Helsinki University Finland: Lilly saatio foundation |
| Information provided by: | Helsinki University |
| ClinicalTrials.gov Identifier: | NCT00565175 |
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 |
Phase IV |
| MedlinePlus related topics: | Schizophrenia |
| ChemIDplus related topics: | Cellulose Cellulose sodium phosphate Phosphocellulose Famotidine Histamine Histamine dihydrochloride Histamine phosphate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia |
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: famotidine
capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks
|
| 2: Placebo Comparator |
Drug: Placebo
Placebo administered in identical capsules as the experimental drug.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jesper Ekelund, MD-PhD | +358-50-3317987 | Jesper.Ekelund@ktl.fi |
| Finland | |||||
| Lohjan sairaanhoitoalue | Not yet recruiting | ||||
| Lohja, Finland, 08450 | |||||
| Contact: Jarmo Laitinen, MD +358-19-3801 700 Jarmo.Laitinen@hus.fi | |||||
| Sub-Investigator: Hannu Saloheimo, MD | |||||
| Principal Investigator: Jarmo Laitinen, MD | |||||
| Kellokosken sairaala | Recruiting | ||||
| Kellokoski, Finland, 04500 | |||||
| Contact: Grigori Joffe, MD-PhD +358-9-2716 3220 Grigori.Joffe@hus.fi | |||||
| Principal Investigator: Grigori Joffe, MD-PhD | |||||
| Peijaksen sairaala | Not yet recruiting | ||||
| Vantaa, Finland, 01450 | |||||
| Contact: Yrjo Lahteenlahti, MD +358-9-471 66530 Yrjo.Lahteenlahti@hus.fi | |||||
| Principal Investigator: Yrjo Lahteenlahti, MD | |||||
| HUCH Department of Psychiatry | Recruiting | ||||
| Helsinki, Finland, 10029 | |||||
| Contact: Jesper Ekelund, MD-PhD +358-9-4711 Jesper.Ekelund@hus.fi | |||||
| Principal Investigator: Jesper Ekelund, MD-PhD | |||||
| Helsinki University |
| Finland: Lilly saatio foundation |
| Principal Investigator: | Jesper Ekelund, MD-PhD | Helsinki University |
More Information
| Responsible Party: | Helsinki University Central Hospital ( Jesper Ekelund, MD-PhD ) |
| Study ID Numbers: | 2006-006636-22, EudraCT: 2006-006636-22 |
| First Received: | November 28, 2007 |
| Last Updated: | January 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00565175 |
| Health Authority: | Finland: National Agency for Medicines; Finland: Ethics Committee |
|
|
|
|
|