Exercise and Severe Depression: Clinical and Biological Analysis

NCT ID: NCT01899716

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aimed to evaluate the use of exercise as a complementary strategy to treat severe major depression in inpatients.

Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe depressed inpatients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Severe Depression Quality of life Exercise BDNF TBARS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise

Aerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aerobic Exercise

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of Major Depressive Disorder according to M.I.N.I (DSM-IV) criteria American Psychiatry Association(1994)
* score of 25 or more on Hamilton-17
* not being involved in other physical activity programs during the hospitalization
* aged between 18 and 60 years
* being able to read, understand, and provide written informed consent

Exclusion Criteria

* have three or more cardiovascular risk factors according to Physical Activity Readiness Questionnaire (PAR-Q)
* are unable to exercise due other clinical condition
* have diagnosis of Schizophrenia, Bipolar disorder or current use of alcohol or other drugs according to M.I.N.I DSM-IV criteria American Psychiatry Association(1994)
* if they are taking beta-blocking medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Felipe B Schuch, MSc

Role: PRINCIPAL_INVESTIGATOR

HCPA

Marcelo PA Fleck, PhD

Role: STUDY_DIRECTOR

HCPA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Clincas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

Schuch FB, Vasconcelos-Moreno MP, Borowsky C, Fleck MP. Exercise and severe depression: preliminary results of an add-on study. J Affect Disord. 2011 Oct;133(3):615-8. doi: 10.1016/j.jad.2011.04.030. Epub 2011 May 25.

Reference Type RESULT
PMID: 21616540 (View on PubMed)

Schuch FB, de Almeida Fleck MP. Is Exercise an Efficacious Treatment for Depression? A Comment upon Recent Negative Findings. Front Psychiatry. 2013 Apr 2;4:20. doi: 10.3389/fpsyt.2013.00020. eCollection 2013. No abstract available.

Reference Type RESULT
PMID: 23565097 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07-438

Identifier Type: -

Identifier Source: org_study_id