NCT06043206

Brief Summary

It is known that schizophrenia is associated with obesity in a significant number of patients and it implies a poor prognostic factor, with weight loss being important in this population. However, data about the prognosis of weight loss surgery in subjects with schizophrenia is scant. Hypothesis: Bariatric surgery in subjects with schizophrenia leads to an improvement in weight and cardiometabolic comorbidities similar to that of subjects without schizophrenia Main goal: To study the evolution after bariatric surgery in patients with obesity and schizophrenia Design: Multicenter retrospective case control study. Disease under study: Schizophrenia and Obesity Methodology: Retrospective observational study Study population and total number of subjects Cases: Patients with schizophrenia and obesity undergoing bariatric surgery. (number: all cases collected within the GOSEEN group). Controls: Patients without psychiatric pathology matched by age, sex, body mass index and type of surgery and in a 4:1 ratio to cases. Calendar. Expected duration of the study. 12 months ethical considerations Informed consent will be obtained from patients who are currently being followed up at the reference centers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

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

October 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 3, 2023

Last Update Submit

September 12, 2023

Conditions

ObesitySchizophrenia

Keywords

Bariatric SurgeryHospital careObservational studyweight lossevolution

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    short (first year after bariatric surgery) and long-term (up to 5 years of follow-up after bariatric surgery) evolution in terms of weight loss of patients with obesity and schizophrenia who underwent bariatric surgery

    12 months and 5 years after the surgery

Secondary Outcomes (4)

  • Clincial Caracteristics description

    inclusion, day 1

  • Comorbidity progression

    12 months and 5 years after the surgery

  • Psychiatric pathology progression

    30 days post surgery and 5 years after the surgery

  • post-surgical complications

    up to 30 days post-surgery) or late post-surgical complications (through study completion, up to five years post-surgery)

Study Arms (2)

Cases Obesity and schizophrenia

Patients with schizophrenia and obesity undergoing bariatric surgery

Procedure: Bariatric Surgery

Controls

Patients without psychiatric pathology matched by age, sex, BMI and type of surgery and in a 4:1 ratio to cases.

Procedure: Bariatric Surgery

Interventions

Bariatric SurgeryPROCEDURE

Bariatric Surgery

Cases Obesity and schizophreniaControls

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects undergoing bariatric surgery

You may qualify if:

  • Controls: in a 4:1 ratio with cases
  • Patients with severe obesity undergoing bariatric surgery and with follow-up in Spanish territory.
  • Absence of psychiatric pathology
  • Paired with the cases by age, sex, BMI before surgery and type of surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

ObesitySchizophreniaWeight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersBody Weight Changes

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2023

First Posted

September 21, 2023

Study Start

October 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

individual participant data can not be available due to the data protection law restrictions, however, anonymized data could be shared on demand

Locations

ES(1)