Histamine H2 Antagonism as Adjuvant Therapy in Treatment... | NCT00565175

Studies
Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia

NCT00565175

Sponsor

Jesper Ekelund

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Schizophrenia

Interventions

famotidine
Placebo (Microcrystallized cellulose)

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006-006636-22	EudraCT Number

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Nov 28, 2007

First Submission Date that Met QC Criteria

Nov 28, 2007

First Posted Date

Nov 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Name	Class
Finland: Lilly saatio foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
famotidine	Experimental		Drug: famotidine
Placebo	Placebo Comparator		Drug: Placebo (Microcrystallized cellulose)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
famotidine	Drug	Capsules containing 100 mg of famotidine p.o., twice daily for 4 weeks.	famotidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scale for the Assessment of Negative Symptoms (SANS) score		5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Positive and Negative Syndrome Scale (PANSS) score		5 weeks
Clinical Global Impression (CGI) score		5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jesper Ekelund, MD-PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HUCH Department of Psychiatry		Helsinki		10029	Finland
Kellokosken sairaala

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23764683	Derived	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.

ID	Term
D012559	Schizophrenia
D000092122	Bronchiolitis Obliterans Syndrome

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles