Exercise for Depression

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-02-28

Brief Summary

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

A randomized single-blinded prospective study to evaluate the efficacy of an individualized supervised 8-week exercise program in subjects with moderate to severe depressive episodes compared to treatment-as-usual

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physical Activity-based Intervention in Depressed Patients: Clinical, Neurophysiological, Epigenetic and Metabolic Correlates

NCT06989944

Major Depressive Disorder (MDD)

RECRUITING NA

Effect of Physical Activity on Depressive Symptoms With a 5 Month Follow-up

NCT01995422

Major Depressive Disorder

COMPLETED NA

Impact of an Eight Week Exercise Intervention in Treating Major Depressive Disorder

NCT03191994

Major Depressive Disorder

UNKNOWN NA

Exercise and Severe Depression: Clinical and Biological Analysis

NCT01899716

Depression

COMPLETED NA

Exercise Recovery From Persistent Depression: A Thematic Analysis

NCT05539495

Major Depressive Disorder Depression Moderate Depression Severe

UNKNOWN

Detailed Description

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

The purpose of this study is to assess the efficacy of a supervised and indvidualized 8-week exercise program compared to treatment-as-usual in subjects with a moderate or severe depressive episode in the context of unipolar depression or bipolar affective disorders. Numerous previous studies suggest that exercise may help to improve the symptoms of depression. Moreover, exercise was shown to enhance neuroplasticity in adults whereas depression results in decreased neuroplasticity. Here, we aim at elucidating whether a newly developed supervised, Internet-based, individualized exercise program of the Institute of Sports Science and the Department of Psychiatry and Psychotherapy at the University Mainz is more effective in reducing depressive symptoms than treatment-as-usual. Furthermore, this study will clarify if severely depressed subjects are able to adhere to an internet-based exercise therapy.

Conditions

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

Depression, Unipolar Bipolar Disorder

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 Group

Experimental arm type will assess whether a newly developed, supervised 8-week individualized, internet-based exercise therapy is effective in reducing depressive symptoms.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

After performance diagnostics, participants will complete an 8-week supervised, individualized exercise program. Training will include up to 3 aerobic training sessions and up to two resistance training units per week.

Treatment as usual group

Treatment as usual. Other form of therapy (e.g. antidepressive medication) will not be affected.

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

After performance diagnostics, participants will complete an 8-week supervised, individualized exercise program. Training will include up to 3 aerobic training sessions and up to two resistance training units per week.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
2. Aged 18 to 65 years old, inclusive, at the time of informed consent.
3. Montral Cognitive Assessment (MoCA) \> 26 to exclude cognitive impairment.
4. Apart from a clinical diagnosis of major depression or bipolar affective disorder, the subject must be in good health as determined by the Investigator, based on medical history and physical examination.
5. QIDS scores \> 5

Exclusion Criteria

1. Use of antidepressive medications or benzodiazepines at doses that have not been stable for at least 6 weeks prior to Screening
2. Psychotherapy that started less than 8 weeks prior to Screening
3. Any clinically significant psychiatric illness other than major depression or bipolar affective disorder
4. Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
5. Any uncontrolled medical or neurological/neurodegenerative condition that, in the opinion of the Investigator, might impair treatment compliance and adherence
6. History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class III or IV), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to Screening
7. Clinically significant 12-lead ECG abnormalities, as determined by the Investigator
8. Uncontrolled hypertension defined as: average of 3 systolic blood pressure \[SBP\]/diastolic blood pressure \[DBP\] readings \> 165/100 mmHg at Screening
9. History of malignancy or carcinoma, with the following exceptions:

i) Subjects with cancers in remission more than 5 years prior to Screening. ii) Subjects with a history of excised or treated basal cell or squamous carcinoma. iii) Subjects with prostate cancer in situ.
10. History of seizure within 2 years prior to Screening.
11. Recent history (within 1 year of Screening) of alcohol or substance abuse as determined by the Investigator, a positive urine drug (due to non-prescription drug) or alcohol test at Screening
12. Clinically significant systemic illness or serious infection (e.g., pneumonia, septicemia) within 30 days prior to or during Screening
13. History of human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
14. Any other medical conditions (e.g., renal disease) that are not stable or controlled, or, which in the opinion of the Investigator, could affect the subject's safety or interfere with the study assessments
15. Female subjects who are pregnant or currently breastfeeding
16. Participation in another study
17. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No