SchizophreniaPhase 2/3NCT01946295
Famotidine in Schizophrenia
A Phase 2/3 study testing Famotidine in people with Schizophrenia, run by Jesper Ekelund at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2014to Aug 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Finland4 sites, 3 recruiting
- Recruiting
Helsinki University Central Hospital Psychiatry Centre
Helsinki
Jesper Ekelund, MD, PhD, jesper.ekelund@helsinki.fi
Grigori Joffe, MD, PhD
- Active, not recruiting
Helsinki University
Helsinki
- Recruiting
Social services and Healthcare, City of Helsinki
Helsinki
Leena Turpeinen, MD
- Recruiting
Kellokoski Hospital
Hyvinkää
Viacheslav Terevnikov, MD, PhD
Viacheslav Terevnikov, MD, PhD
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska Institutet
Stockholm, 17177
Jari Tiihonen, MD, PhD, jari.tiihonen@ki.se
Jari Tiihonen, MD, PhD
- Recruiting
Norra Stockholms Psykiatri, Stockholm County Council
Stockholm
Christina Lagerbäck, MD
About this study
Official title: Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
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.
- Conditions
- Schizophrenia
- Being tested
- Famotidine, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamotidineDrug
Also called Famotidine Hexal, SUB07503MIG
100mg x 2 p.o.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Famotidine | Experimental | Famotidine 100mg x 2 orally Receives: Drug: Famotidine |
| Placebo | Placebo comparator | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
In addition CGI ratings are done at screening, every two weeks during treatment and two weeks after end of treatment.
Measured: 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
Measured: 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
Measured: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)
Change from Baseline in CogState scores at 8 weeks
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.
Measured: 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
Average nightly sleep duration of seven nights before and after intervention measured with an actigraph
Measured: Measurement at start of treatment (0 weeks) and at end of treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesper Ekelund
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Region Stockholm, City of Helsinki, Stanley Medical Research Institute, Ahokas foundation, Finland
- Responsible party
- Sponsor-investigator, Jesper Ekelund, University of Helsinki
- Investigators
- Jesper Ekelund, MD, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946295
- Sponsor's protocol ID
- 2012-005513-40
- Status last verified
- Apr 2015
- First submitted
- 23 Aug 2013
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23764683
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT01946295
- Acronym / sponsor ID
- 2012-005513-40
- Conditions
- Schizophrenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Jesper EkelundUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Region Stockholm, City of Helsinki, Stanley Medical Research Institute, Ahokas foundation, Finland
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Famotidine | Experimental | Drug: FamotidineFamotidine 100mg x 2 orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamotidineAlso: Famotidine Hexal, SUB07503MIG100mg x 2 p.o. | Drug | Famotidine |
| Placebo | Drug | Placebo |
Primary outcome
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)
In addition PANSS ratings are done at screening, every two weeks during treatment and two weeks after end of treatment.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Background: PubMed 23764683Meskanen 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.
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Ekelund, MD, PhD principal investigator
University of Helsinki
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Famotidine in people with Schizophrenia, run by Jesper Ekelund at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesper Ekelund, MD,PhD (+358503317987, jesper.ekelund@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01946295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.