Antipsychotics and Gene Expression in Soft Tissues | NCT01185743

Studies
Antipsychotics and Gene Expression in Soft Tissues

NCT01185743

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Mar 23, 2017Actual

Enrollment

16Actual

Phase

Phase 4

Conditions

Schizophrenia
Diabetes

Interventions

olanzapine
ziprasidone
placebo

Countries

Austria

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

Status Module

Record Verification Date

Mar 2017

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

Jul 2010

Primary Completion Date

Jan 1, 2017Actual

Completion Date

Jan 1, 2017Actual

First Submitted Date

Aug 19, 2010

First Submission Date that Met QC Criteria

Aug 19, 2010

First Posted Date

Aug 20, 2010Estimated

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 22, 2017

Last Update Posted Date

Mar 23, 2017Actual

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

Schizophrenia is a severe chronic and disabling mental disorder and is associated with a significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid metabolism.

Aim: to gain data on drug related effects on gene expression and regulation with special regard to glucose metabolism.

Detailed Description

Not provided

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
olanzapine	Active Comparator	olanzapine	Drug: olanzapine Drug: ziprasidone
ziprasidone	Active Comparator	ziprasidone	Drug: olanzapine Drug: ziprasidone
Sugar pill	Placebo Comparator	Sugar pill	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olanzapine	Drug	olanzapine 10mg od + placebo od	olanzapine ziprasidone

Measure	Description	Time Frame
gene expression profiling	To characterize and compare the gene expression profiles in human subcutaneous adipose and muscle tissue prior and after single dose of olanzapine, ziprasidone and placebo.	10 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male.
Healthy, defined as absence of relevant diseases.
Caucasian.
Aged 18-45 years.
Body-Mass-Index (BMI): 18-25 kg/m2.
Signed informed consent.
No signs of impaired glucose tolerance as evaluated by Oral Glucose Tolerance Test (OGTT) before study inclusion during screening, normal total cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), triglycerides, normal function of the thyroid. No personal or family history (parents and siblings) of diabetes or other metabolic and relevant diseases as defined by the investigator.
No indication for psychiatric diseases assessed by structured clinical interview (Mini-International Neuropsychiatric Interview (MINI)).

Exclusion Criteria:

Personal or family history (parents and siblings) of diabetes or other metabolic diseases, relevant diseases as defined by the investigator.
History of hypertension, blood pressure > 140/90 at screening, cardiovascular disease.
Body mass index out of the range of <18 and >25 kg/m.
Human immunodeficiency virus (HIV) or Hepatitis B/C positive virology.
Allergy or hypersensitivity against olanzapine/ziprasidone or another excipient.
Contraindications against the use of the drug according to the Summary of Product Characteristics (SmPC).
Any drug intake 2 weeks prior to first study day.
History of excessive bleeding tendency/hemophilia.
Presence of relevant illness within the last 3 weeks.
Currently enrolled into an other clinical study with Investigational Medicinal Products (IMPs).
Last study participation less than 4 weeks.
Suspected non-compliance with study instructions and life-style requirements.
History of alcohol or drug abuse.
Blood/Plasma donation within 4 weeks prior to study day.
Previous exposure to antipsychotic drugs.
Nicotine consumption at time of enrolment (at least 3 months of non-smoking required).

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012559	Schizophrenia
D003920	Diabetes Mellitus

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D000077152	Olanzapine
C092292	ziprasidone

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring