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Famotidine in Schizophrenia

J

Jesper Ekelund

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Schizophrenia

Treatments

Drug: Placebo
Drug: Famotidine

Study type

Interventional

Funder types

Other

Identifiers

NCT01946295
2012-005513-40

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

140 participants in 2 patient groups, including a placebo group

Famotidine
Experimental group
Description:
Famotidine 100mg x 2 orally
Treatment:
Drug: Famotidine
Placebo
Placebo Comparator group
Description:
Placebo control
Treatment:
Drug: Placebo

Trial contacts and locations

6

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Central trial contact

Jesper Ekelund, MD,PhD

Data sourced from clinicaltrials.gov

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