Antipsychotic Medicine and Metabolic Syndrome
AMMS1
Changes in Enteroendocrine and Neuroendocrine Axes in Patients With Weight Gain After Treatment With Antipsychotics
2 other identifiers
observational
100
1 country
2
Brief Summary
The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and a quality of life. The investigators expect, that 30-50% of patients will show pharmacon - gene induced weight gain (\> 7% of initial bodyweight) while the rest of patients will maintain unaltered bodyweight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2008
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 22, 2008
CompletedFirst Posted
Study publicly available on registry
March 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 30, 2010
July 1, 2010
2 years
February 22, 2008
July 29, 2010
Conditions
Keywords
Study Arms (2)
Food challenge test
Patients 51 patients included
C
Controls 93 healthy controls are included
Eligibility Criteria
50 patients and 100 control persons. Patients should be treated with minimum one antipsychotic drug and hospitalized or treated as out-patients at Glostrup, Ballerup or Gentofte hospitals. Controls will be chosen from the database at Institute of Health and Prevention, Glostrup.
You may qualify if:
- gender : male
- age: 18-45
- treatment with minimum one Antipsychotic drug (AP)
- ethnicity: caucasians
- consent given to take part in the project
You may not qualify if:
- One criteria is sufficient to exclude patients from the study:
- compliance problems
- unable to read, write and talk Danish
- patients with major lung-,heart-, lever- and kidney problems
- patients with diagnose and treatment for Diabetes 1 and 2
- patients taking cholesterol-reducing, weight-reducing and antihypertensive medication
- patients with abuse of alcohol or drugs
- patients who are under duress §
- patients who have been mentally ill for more than 15 years
- patients with diagnosis/treatment for NIDDM/IDDM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glostrup University Hospital, Copenhagenlead
- University Hospital, Gentofte, Copenhagencollaborator
- University of Copenhagencollaborator
Study Sites (2)
Psychiatric University Center Glostrup
Copenhagen, Glostrup, 2600, Denmark
Psychiatric University Center Glostrup
Copenhagen, Glostrup, 2600, Denmark
Related Publications (1)
Ebdrup BH, Knop FK, Madsen A, Mortensen HB, Sogaard B, Holst JJ, Szecsi PB, Lublin H. Glucometabolic hormones and cardiovascular risk markers in antipsychotic-treated patients. J Clin Psychiatry. 2014 Sep;75(9):e899-905. doi: 10.4088/JCP.13m08820.
PMID: 25295432DERIVED
Biospecimen
whole blood, serum, plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Lublin, MD DMSc
Glostrup University Hospital, Copenhagen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 22, 2008
First Posted
March 3, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2010
Study Completion
December 1, 2010
Last Updated
July 30, 2010
Record last verified: 2010-07