SchizophreniaPhase 4NCT00565175
Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
A Phase 4 study testing famotidine in people with Schizophrenia, run by Jesper Ekelund at 5 sites in Finland.
Trial 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. 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
- 30 participants
- Where
- 5 sitesFinland
- Study dates
- Jan 2008to Dec 2011
- Phase
- Phase 4
- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
HUCH Department of Psychiatry
Helsinki, 10029
Kellokosken sairaala
Kellokoski, 04500
Lohjan sairaanhoitoalue
Lohja, 08450
Vaasa Hospital District
Vaasa
Peijaksen sairaala
Vantaa, 01450
About this study
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.
Read the detailed description
Histamine functions as a neurotransmitter in the brain. It has an important role as modulator of the release of other neurotransmitters, including dopamine.
The histamine receptors are widely expressed in the brain, H1 and H2 receptors are post-synaptic, H3 a pre-synaptic autoreceptor. There is an abundance of neurobiologic data from animal and human studies supporting the role of histamine in the pathogenesis and treatment of psychoses.
In 1990 a case report of a treatment resistant subject with schizophrenia whos symptoms improved markedly when he was prescribed a H2 antagonist because of peptic ulcer. Later, a open-label trial including 18 patients has been performed, reporting significant symptom reduction, especially on negative symptoms. Also the subjective comments both by the subjects and the investigators in that study were optimistic and suggested an effect primarily on negative symptoms.
The present study will be the first double-blind, randomized, placebo controlled, parallel group study of the subject matter. The study focuses on treatment resistant schizophrenia cases in the stable phase.
- Conditions
- Schizophrenia
- Being tested
- famotidine, Placebo (Microcrystallized cellulose)
- Keywords
- Treatment resistant, Chronic
- Medical subject headings
- Schizophrenia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
famotidineDrug
Also called Famotidin Hexal
Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.
Placebo (Microcrystallized cellulose)Drug
Also called Microcrystallized cellulose
Placebo administered in identical capsules as the experimental drug.
| Study group | Role | What they receive |
|---|---|---|
| famotidine | Experimental | Not described Receives: Drug: famotidine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (Microcrystallized cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the Assessment of Negative Symptoms (SANS) score
Measured: 5 weeks
Secondary outcomes (2)
Positive and Negative Syndrome Scale (PANSS) score
Measured: 5 weeks
Clinical Global Impression (CGI) score
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesper Ekelund
- Sponsor type
- University, hospital or other
- Collaborators
- Finland: Lilly saatio foundation
- Responsible party
- Sponsor-investigator, Jesper Ekelund, University of Helsinki
- Investigators
- Jesper Ekelund, MD-PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565175
- Sponsor's protocol ID
- 2006-006636-22
- Other IDs
- 2006-006636-22
- Status last verified
- Mar 2012
- First submitted
- 28 Nov 2007
- Last updated
- 20 Mar 2012
- 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 20 Mar 2012. 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
- NCT00565175
- Acronym / sponsor ID
- 2006-006636-22
- Conditions
- Schizophrenia
- Keywords
- Treatment resistant, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jesper EkelundUniversity, hospital or other
- Collaborators
- Finland: Lilly saatio foundation
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Nov 2007 (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.
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.
Detailed description
Histamine functions as a neurotransmitter in the brain. It has an important role as modulator of the release of other neurotransmitters, including dopamine.
The histamine receptors are widely expressed in the brain, H1 and H2 receptors are post-synaptic, H3 a pre-synaptic autoreceptor. There is an abundance of neurobiologic data from animal and human studies supporting the role of histamine in the pathogenesis and treatment of psychoses.
In 1990 a case report of a treatment resistant subject with schizophrenia whos symptoms improved markedly when he was prescribed a H2 antagonist because of peptic ulcer. Later, a open-label trial including 18 patients has been performed, reporting significant symptom reduction, especially on negative symptoms. Also the subjective comments both by the subjects and the investigators in that study were optimistic and suggested an effect primarily on negative symptoms.
The present study will be the first double-blind, randomized, placebo controlled, parallel group study of the subject matter. The study focuses on treatment resistant schizophrenia cases in the stable phase.
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: famotidine |
| Placebo | Placebo comparator | Drug: Placebo (Microcrystallized cellulose) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Epilepsy or a history of unclear seizures
- Stroke
- Parkinson's disease
- AIDS
- Substance addiction or abuse within 3 months prior to enrolment.
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: Famotidin HexalCapsules containing 100 mg of famotidine p.o., twice daily for 4 weeks. | Drug | famotidine |
| Placebo (Microcrystallized cellulose)Also: Microcrystallized cellulosePlacebo administered in identical capsules as the experimental drug. | Drug | Placebo |
Primary outcome
Scale for the Assessment of Negative Symptoms (SANS) score
Time frame: 5 weeks
2 secondary outcomes
Positive and Negative Syndrome Scale (PANSS) score
Time frame: 5 weeks
Clinical Global Impression (CGI) score
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Derived from this study: 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.
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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
Helsinki University Central Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing famotidine in people with Schizophrenia, run by Jesper Ekelund at 5 sites in Finland.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for the Assessment of Negative Symptoms (SANS) score (time frame: 5 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 NCT00565175, 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 20 Mar 2012.