Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06043206 |
| Other study ID # |
IIBSP-BAR-2022-30 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
THEORETICAL FRAMEWORK. PROBLEM STATEMENT:
Background Obesity affects approximately 45-55% of patients with schizophrenia (1). Weight
gain in these patients may be due to different factors such as the use of antipsychotic drugs
with an unfavorable metabolic profile, the coexistence of sleep disorders or negative
cognitive symptoms that often translate into a more sedentary lifestyle and alterations in
eating behavior, among others (2). The coexistence of obesity and its comorbidities in this
group of patients significantly worsens both their physical and mental health (3). In fact,
cardiovascular disease is one of the main causes of mortality in patients with schizophrenia
(4).
Lifestyle interventions, while they may be effective in people with schizophrenia (5), often
fall short of achieving weight goals. At present, obesity surgery represents the most
effective treatment in terms of weight loss and resolution of comorbidities, being indicated
in cases of patients with a body mass index (BMI) > 35 kg/m2 with comorbidities or BMI > 40
Kg/m2 with/without comorbidities. However, the access of patients with schizophrenia to
bariatric surgery techniques is usually limited by different factors such as fear of a
possible worsening of the underlying disease, or a lower weight loss in this population,
among others. In addition, clinical practice guidelines recommend that all patients with
psychiatric pathologies be evaluated in a regulated manner prior to surgery (6), although the
content of this evaluation and the criteria for declining or accepting surgery are not clear.
Although the course of schizophrenia is variable and its symptoms may be stable without being
a clear contraindication for bariatric surgery, in actual practice, a considerable number of
professionals contraindicate bariatric surgery in the presence of a psychotic disorder (7).
For these reasons, data on the efficacy of bariatric surgery in patients with schizophrenia
are scarce and limited to very small case series with short-term follow-up (2,8,9). Our
objective is therefore to carry out a multicenter retrospective study that allows us to study
the long-term evolution after bariatric surgery in a large series of patients, focusing not
only on weight evolution but also on the long-term evolution of psychiatric pathology.
Justification It is necessary to have information about the prognosis of subjects with severe
obesity and schizophrenia who undergo bariatric surgery. This knowledge will make it possible
to establish clear guidelines for action in these cases.
Research questions What is the long-term outcome after bariatric surgery in subjects with
schizophrenia? Hypothesis Bariatric surgery in subjects with schizophrenia leads to an
improvement in weight and cardiometabolic comorbidities similar to that of subjects without
schizophrenia
GOALS:
Main goal:
To study the 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 in Spain and compare it with the evolution
of patients without psychiatric disorder.
Secondary objectives:
- Determine the casuistry of patients, with special interest in the characteristics of the
underlying psychiatric pathology (years of evolution, clinical stability criteria,
pharmacological treatment...).
- To Analyze the evolution of obesity comorbidities.
- To Analyze the evolution of psychiatric pathology after bariatric surgery:
(decompensation, drug treatment...)
- To analyze the frequency of early (<30 days post-surgery) or late (>30 days
post-surgery) post-surgical complications.
METHODS:
Study design Retrospective case-control study.
Expected sample size All cases detected in Spanish territory The minimum number of cases
expected will be 10 patients based on the low casuistry of the problem. The number of
patients in the control group will be x4 that in the study group.
Methodology. Information sources The study population will be identified in each center in
the usual specialty consultations or by searching the databases of each center. Review of
medical records in search of the specified variables (retrospective observational study).
Data Management and Analysis The coordinating researcher (Dra Inka Miñambres Donaire) will be
responsible for the creation of the database and its exploitation. The database will be
created in Excell format and the SPSS program will be used for statistical analysis. The
statistics will be mainly descriptive. For cases in which it is decided to compare groups,
normality tests will be used to establish the behavior of the variables and
parametric/non-parametric tests will be used as appropriate.
Data collection The researcher will guarantee the accuracy and integrity of the data, as well
as all the reports that are required. The data included in the Data Collection Notebook
(CRD), which are derived from source documents, will be consistent with those documents or
otherwise the discrepancies will be justified.
The researcher will keep the study documents until at least 5 years after completion.
At the request of the monitor, auditor, ethics committee or health authority, the researcher
will have available all the files related to the study, allowing direct access to the data or
source documents for monitoring, auditing, review by the ethics committee, as well as the
inspection of the trial by the competent authorities.
Limitations of the design, the source of information and the methods of analysis
The main limitation of the study is its retrospective nature. However, the study design is
adequate given the low frequency of the pathology.
Data confidentiality Regarding the confidentiality of the study data, the provisions of
Organic Law 3/2018, of December 5, on the Protection of Personal Data and Guarantee of
Digital Rights and the General Regulation (EU) on Data Protection will be followed. 2016/679.
Interference with physician's prescribing habits As it is a retrospective study, there will
be no interference with the prescribing habits of the doctor.
