Famotidine in Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Helsinki University
Sponsor:
Collaborators:
Karolinska Institutet
Stockholm County Council, Sweden
Social services and Healthcare, City of Helsinki, Finland
Stanley Medical Research Institute
Ahokas foundation, Finland
Information provided by (Responsible Party):
Jesper Ekelund, Helsinki University
ClinicalTrials.gov Identifier:
NCT01946295
First received: August 23, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

Objective of the trial is to study if famotidine add-on treatment is more effective than placebo add-on in reducing symptoms of schizophrenia among patients receiving insufficient response to ongoing antipsychotic treatment.


Condition Intervention Phase
Schizophrenia
Drug: Famotidine
Drug: Placebo
Phase 2
Phase 3

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
Official Title: Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at 8 weeks [ Time Frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks) ] [ Designated as safety issue: No ]
    In addition PANSS ratings are done at screening, every two weeks during treatment and two weeks after end of treatment.


Secondary Outcome Measures:
  • Change from Baseline in Clinical Global Impression (CGI) scale at 8 weeks [ Time Frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks) ] [ Designated as safety issue: No ]
    In addition CGI ratings are done at screening, every two weeks during treatment and two weeks after end of treatment.

  • Change from Baseline in Calgary Depression Scale (CDS) at 8 weeks [ Time Frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks) ] [ Designated as safety issue: No ]
  • Change from Baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)at 8 weeks [ Time Frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks) ] [ Designated as safety issue: No ]
  • Change from Baseline in CogState scores at 8 weeks [ Time Frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks) ] [ Designated as safety issue: No ]
    A standardized, language independent computerized battery of cognitive tests (CogState®). This battery has been validated and shown to be a sensitive indicator of mild impairments in the following cognitive domains: psychomotor speed, attention, working memory and episodic learning and memory.

  • Change from baseline in nightly sleep duration measured with actigraphy at 8 weeks [ Time Frame: Measurement at start of treatment (0 weeks) and at end of treatment (8 weeks) ] [ Designated as safety issue: No ]
    Average nightly sleep duration of seven nights before and after intervention measured with an actigraph


Estimated Enrollment: 140
Study Start Date: March 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Famotidine
Famotidine 100mg x 2 orally
Drug: Famotidine
100mg x 2 p.o.
Other Names:
  • Famotidine Hexal
  • SUB07503MIG
Placebo Comparator: Placebo
Placebo control
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICD-10 diagnosis of schizophrenia (F20.00-20.39, F20.5, F20.9) who have had the disorder for at least 5 years and who are on disability pension. (This means that their treatment response is not satisfactory and for the purpose of this study, the subjects are potentially treatment resistant).
  • Clinical Global Impression (CGI) severity score of at least 3.
  • No changes in schizophrenia treatment within 12 weeks before study inclusion.
  • Written informed consent
  • The subjects must fulfil schizophrenia criteria both according to DSM- IV (295.10, .20, .30, .60, .90) (American Psychiatric association) and the Research Diagnostic Criteria for schizophrenia (RDC) [40]. They must also have at least mild residual symptoms (CGI 3 points). The DSM-IV diagnosis will be verified by use of the SCID-I [41]. The DSM-IV is clearly the most commonly used in psychiatric research, so this is important to be able to generalize the findings. However, several previous studies have used the RDC, so to be able to compare the results, we will diagnose the patients according to both systems.
  • Women of child-bearing age will be included only of they use adequate contraception, or if we can otherwise verify that the subject is not pregnant (s-HCG), the possibility of pregnancy is negligible (e.g. the personnel of the housing facility reports that the person has not had sexual relationships for years) and the subject approves to remain sexually abstinent for the duration of the study.

Exclusion Criteria:

  • Epilepsy or a history of unclear seizures, stroke, Parkinson's disease, AIDS
  • History of substance addiction or abuse within 3 months prior to enrolment.
  • Individuals who are deemed at risk for aggressive behaviour or suicide
  • If their laboratory tests, EKG or other clinical observation warrants exclusion, they will be excluded
  • Women who are pregnant or breast-feeding subjects will not be included in the study.
  • Patients with any serious unstable physical illness will also be excluded
  • Patients who have been deemed to be legally incapacitated according to Finnish or Swedish law.
  • Regular Uuse of H2-antagonists as prescribed by a physician.
  • Known allergy to famotidine or any other component of interventional drug will be excluded.
  • Ongoing treatment with clozapine and dixyrazine.
  • Clinical condition "very much improved" or "much improved", assessed by CGI, during the placebo lead-in
  • Renal insufficiency (P-creatinine not within normal range. Glomerular filtration rate <30 ml/min according to the Cockcroft-Gault formula. )
  • Liver insufficiency (S-ALAT elevated more than 2-fold above the laboratory specific normal range)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946295

Contacts
Contact: Jesper Ekelund, MD,PhD +358503317987 jesper.ekelund@helsinki.fi

Locations
Finland
Helsinki University Central Hospital Psychiatry Centre Recruiting
Helsinki, Finland
Contact: Jesper Ekelund, MD, PhD       jesper.ekelund@helsinki.fi   
Sub-Investigator: Grigori Joffe, MD, PhD         
Principal Investigator: Jesper Ekelund, MD,PhD         
Sub-Investigator: Katarina Meskanen, MSc         
Sub-Investigator: Roope Heikkila, MSc         
Social services and Healthcare, City of Helsinki Recruiting
Helsinki, Finland
Principal Investigator: Leena Turpeinen, MD         
Helsinki University Active, not recruiting
Helsinki, Finland
Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden, 17177
Contact: Jari Tiihonen, MD, PhD       jari.tiihonen@ki.se   
Principal Investigator: Jari Tiihonen, MD, PhD         
Norra Stockholms Psykiatri, Stockholm County Council Recruiting
Stockholm, Sweden
Principal Investigator: Christina Lagerbäck, MD         
Sponsors and Collaborators
Jesper Ekelund
Karolinska Institutet
Stockholm County Council, Sweden
Social services and Healthcare, City of Helsinki, Finland
Stanley Medical Research Institute
Ahokas foundation, Finland
Investigators
Principal Investigator: Jesper Ekelund, MD, PhD Helsinki University
  More Information

Publications:
Responsible Party: Jesper Ekelund, Professor, Helsinki University
ClinicalTrials.gov Identifier: NCT01946295     History of Changes
Other Study ID Numbers: 2012-005513-40
Study First Received: August 23, 2013
Last Updated: May 5, 2014
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014