CClinicalTrials.gg
Sign In
CompletedNCT00169702Updated Jan 30, 2008

The Effect of a Weight Management Program During Treatment With Olanzapine

An interventional study of weight management program and weight management program in Schizophrenia, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-01-30.

Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The study is a prospective, randomized, open-label study.

Read the detailed description

The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.

02

Conditions studied

  • Schizophrenia

Browse trials for

Keywords

  • Schizophrenia, weight management programme
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
  • Ages between 18 and 65
  • Informed consent
  • Weight gain of at least 1.5 kg in the first 4 weeks
  • A sufficient understanding to participate adequately in the weight management program
  • Patients must agree to cooperate with all tests and examinations required by the protocol.
  • Each patient must understand the nature of the study and must sign an informed consent document.

Exclusion criteria

Exclusion Criteria:

  • Serious, unstable somatic illnesses
  • Illnesses associated with weight gain including renal and endocrine diseases
  • Weight change greater than 3 kg in the preceding three months
  • Weight gain less than 1.5 kg in the first 4 weeks
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Other
    Standard

    standard information

    Behavioral: weight management program

  • Active comparator
    Intervention

    weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.

    Behavioral: weight management program

Interventions

  • Behavioralweight management program

    12 sessions, psychoeducation

  • Behavioralweight management program

    2 weekly, 12 sessions, psychoeducational weight management

06

What researchers measure

Primary outcomes

  1. difference in mean weight gain

    Time frame: November 2007

Secondary outcomes

  1. changes in waist circumference, blood pressure, blood lipids, fasting glucose

    Time frame: November 2007

07

Study locations

1 site
  • Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
    Düsseldorf, Rhineland State 40629, Germany
08

References and documents

Publications

  • Hauner H, Rohrig K, Hebebrand J, Skurk T. No evidence for a direct effect of clozapine on fat-cell formation and production of leptin and other fat-cell-derived factors. Mol Psychiatry. 2003 Mar;8(3):258-9. doi: 10.1038/sj.mp.4001246. No abstract available. PubMed 12660797 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00169702
Lead sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
Eli Lilly and Company, Else Kröner-Fresenius-Centre for Nutritional Medicine, Technical University of Munich
First posted
Sep 15, 2005
Start date
Jun 2003
Completion
Jul 2007
Last update
Jan 30, 2008

Study contacts

Joachim Cordes, MD
principal investigator · Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, Germany
Ansgar Klimke, Prof
study director · Department of Psychiatry, Offenbach
Hans Hauner, Prof
study director · Technical University of Munic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Schizophrenia→

Other studies from this sponsor

Heinrich-Heine University, Duesseldorf

Start the discussion