NCT00980863

Brief Summary

Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases the risk for somatic disease and non-adherence to maintenance therapy. Therefore, interventions addressing weight gain are expedient for the management of this disorder. The investigators set out to evaluate the effects of a lifestyle intervention on body mass index, cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood stabilizing treatment participated in a randomized controlled trial (waiting control group N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two cohorts. The intervention lasted five months and consisted of eleven group sessions and weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular, glycemic and metabolic parameters were determined as baseline (March and September 2005) and after five (July 2005 and January 2006) and eleven months (January and July 2006).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

1.4 years

First QC Date

September 18, 2009

Last Update Submit

September 18, 2009

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • BMI

    11 months

Study Arms (2)

Lifestyle intervention to increase physical activity

ACTIVE COMPARATOR
Behavioral: lifestyle intervention to increase physical activity

waiting control group

NO INTERVENTION
Behavioral: lifestyle intervention to increase physical activity

Interventions

lifestyle intervention to increase physical activityBEHAVIORAL
Lifestyle intervention to increase physical activitywaiting control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fulfilled the diagnostic criteria for bipolar disorder according to DSM-IV-TR,27;
  • were on treatment with medication for at least three months with one of the following substances: lithium, valproic acid carbamazepine, oxcarbazepine, olanzapine, quetiapine, risperidone, amisulpride; and
  • were not underweight (BMI \> 20 kg/m2).

You may not qualify if:

  • Pregnancy
  • Actual breast feeding
  • A diagnosis of anorexia nervosa or bulimia nervosa
  • Diabetes type I or II or another serious physical disease
  • Use of substances that reduce weight (e.g., topiramate, lamotrigine as mood stabilizer in monotherapy)
  • Participants with comorbidity of acute psychosis, drug addiction, personality disorder, suicidal tendencies or a current severe manic or depressive episode were excluded only if attending the program was not possible due to the respective disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorium Kilchberg

Zurich, Switzerland

Location

Related Publications (1)

  • Gillhoff K, Gaab J, Emini L, Maroni C, Tholuck J, Greil W. Effects of a multimodal lifestyle intervention on body mass index in patients with bipolar disorder: a randomized controlled trial. Prim Care Companion J Clin Psychiatry. 2010;12(5):PCC.09m00906. doi: 10.4088/PCC.09m00906yel.

    PMID: 21274359DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Waldemar Greil, Professor

    Sanatorium Kilchberg, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

March 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

CH(1)