Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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famotidine

Group Type EXPERIMENTAL

famotidine

Intervention Type DRUG

Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo (Microcrystallized cellulose)

Intervention Type DRUG

Placebo administered in identical capsules as the experimental drug.

Interventions

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famotidine

Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.

Intervention Type DRUG

Placebo (Microcrystallized cellulose)

Placebo administered in identical capsules as the experimental drug.

Intervention Type DRUG

Other Intervention Names

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Famotidin Hexal Microcrystallized cellulose

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No