NCT00565175

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2008

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

3.9 years

First QC Date

November 28, 2007

Last Update Submit

March 19, 2012

Conditions

Schizophrenia

Keywords

Treatment resistantChronic

Outcome Measures

Primary Outcomes (1)

  • Scale for the Assessment of Negative Symptoms (SANS) score

    5 weeks

Secondary Outcomes (2)

  • Positive and Negative Syndrome Scale (PANSS) score

    5 weeks

  • Clinical Global Impression (CGI) score

    5 weeks

Study Arms (2)

famotidine

EXPERIMENTAL
Drug: famotidine

Placebo

PLACEBO COMPARATOR
Drug: Placebo (Microcrystallized cellulose)

Interventions

famotidineDRUG

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

Also known as: Famotidin Hexal
famotidine
Placebo (Microcrystallized cellulose)DRUG

Placebo administered in identical capsules as the experimental drug.

Also known as: Microcrystallized cellulose
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

HUCH Department of Psychiatry

Helsinki, 10029, Finland

Location

Kellokosken sairaala

Kellokoski, 04500, Finland

Location

Lohjan sairaanhoitoalue

Lohja, 08450, Finland

Location

Vaasa Hospital District

Vaasa, Finland

Location

Peijaksen sairaala

Vantaa, 01450, Finland

Location

Related Publications (1)

  • Meskanen K, Ekelund H, Laitinen J, Neuvonen PJ, Haukka J, Panula P, Ekelund J. A randomized clinical trial of histamine 2 receptor antagonism in treatment-resistant schizophrenia. J Clin Psychopharmacol. 2013 Aug;33(4):472-8. doi: 10.1097/JCP.0b013e3182970490.

    PMID: 23764683DERIVED

MeSH Terms

Conditions

SchizophreniaBronchiolitis Obliterans Syndrome

Interventions

Famotidine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jesper Ekelund, MD-PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of psychiatry

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 29, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

FI(5)