NCT00636753

Brief Summary

The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and quality of life.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

July 30, 2010

Status Verified

July 1, 2010

Enrollment Period

10 months

First QC Date

March 7, 2008

Last Update Submit

July 29, 2010

Conditions

Metabolic Syndrome

Keywords

Metabolic and endocrine changes in schizophrenic patients by antipsychotics treatment.

Study Arms (2)

1

schizophrenic patients

2

controls

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients with debut of schizophrenia, controls from database

You may qualify if:

  • Gender male
  • Age 18-45
  • Debut drug-naive schizophrenics,
  • Caucasians
  • Consent given to take part in the project

You may not qualify if:

  • Compliance-problems
  • Major lung-/kidney/hart/lever disorders
  • Abuse of alcohol/drugs
  • Diabetes 1 and 2
  • Antihypertensive
  • Anticholesterol-reducing medication
  • Patients under duress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Psychiatric Center Glostrup

Copenhagen, Nordre Ringvej 28-69, Glostrup, 2600, Denmark

Location

Psychiatric Center Glostrup

Nordre Ringvej 28-69, Glostrup, 2600, Denmark

Location

Biospecimen

Retention: NONE RETAINED

whole blood, serum/plasma

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Last Updated

July 30, 2010

Record last verified: 2010-07

Locations

DK(2)