NCT01946295

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Mar 2014

Typical duration for phase_2 schizophrenia

Geographic Reach
2 countries

6 active sites

Status
unknown

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

August 23, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

August 23, 2013

Last Update Submit

April 13, 2015

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at 8 weeks

    In addition PANSS ratings are done at screening, every two weeks during treatment and two weeks after end of treatment.

    Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)

Secondary Outcomes (5)

  • Change from Baseline in Clinical Global Impression (CGI) scale at 8 weeks

    Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)

  • Change from Baseline in Calgary Depression Scale (CDS) at 8 weeks

    Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)

  • Change from Baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)at 8 weeks

    Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)

  • Change from Baseline in CogState scores at 8 weeks

    Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)

  • Change from baseline in nightly sleep duration measured with actigraphy at 8 weeks

    Measurement at start of treatment (0 weeks) and at end of treatment (8 weeks)

Study Arms (2)

Famotidine

EXPERIMENTAL

Famotidine 100mg x 2 orally

Drug: Famotidine

Placebo

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Interventions

FamotidineDRUG

100mg x 2 p.o.

Also known as: Famotidine Hexal, SUB07503MIG
Famotidine
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Helsinki University Central Hospital Psychiatry Centre

Helsinki, Finland

RECRUITING

Helsinki University

Helsinki, Finland

ACTIVE NOT RECRUITING

Social services and Healthcare, City of Helsinki

Helsinki, Finland

RECRUITING

Kellokoski Hospital

Hyvinkää, Finland

RECRUITING

Karolinska Institutet

Stockholm, 17177, Sweden

RECRUITING

Norra Stockholms Psykiatri, Stockholm County Council

Stockholm, Sweden

RECRUITING

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: 23764683BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Famotidine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jesper Ekelund, MD, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper Ekelund, MD,PhD

CONTACT

+358503317987jesper.ekelund@helsinki.fi

Study Design

Study Type
interventional
Phase
phase 2
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

Study Record Dates

First Submitted

August 23, 2013

First Posted

September 19, 2013

Study Start

March 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

FI(4)SE(2)