Exercise for Depression (EXDEP)

February 28, 2018 updated by: Prof. Dr. Dr. Perikles Simon, Johannes Gutenberg University Mainz

The Efficacy of Exercise in Depressive Episodes of Unipolar Depression and Bipolar Affective Disorders

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55099
        • Department of Psychiatry and Psychotherapy, University Medical Center, Mainz
      • Mainz, Rhineland-Palatinate, Germany, 55099
        • Department of Sports Medicine, Johannes Gutenberg University, Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: Treatment as usual group
Treatment as usual. Other form of therapy (e.g. antidepressive medication) will not be affected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - clinical rating-16 (QIDS C-16)
Time Frame: 8 weeks
Change of Score on the QIDS C-16 after 8 weeks compared to baseline.
8 weeks
Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - self-report-16 (QIDS SR-16)
Time Frame: 8 weeks
Change of Score on the QIDS SR-16 after 8 weeks compared to baseline.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence of internet-based concept
Time Frame: 8 weeks
Adherence of internet-based concept using an own questionnaire. Participants respond at the end of every week how they managed their individualized exercise schedule in terms of number of realised training sessions, average heart rate and subjective perceived exertion.
8 weeks
Placebo effect of exercise (QIDS-SR16)
Time Frame: 8-10 days
Change of Score on the QIDS-SR16 after one week of training to determine placebo effect of exercise.
8-10 days
Placebo effect of exercise (QIDS-C16)
Time Frame: 8-10 days
Change of Score on the QIDS-C16 after one week of training to determine placebo effect of exercise.
8-10 days
Peak oxygen uptake (VO2peak)
Time Frame: 8 weeks
Change of VO2peak after 8 weeks compared to baseline. Participants will be subjected to a step-wise treadmill test at baseline and after 8 weeks.
8 weeks
Lactate threshold
Time Frame: 8 weeks
Change of lactate threshold using the baseline +1.5 mmol model after 8 weeks compared to baseline.
8 weeks
Short form 36 (SF36) health survey questionnaire
Time Frame: 8 weeks
Change of score on the SF-36 after 8 weeks compared to baseline.
8 weeks
General self efficacy questionnaire (GSE)
Time Frame: 8 weeks
Change of score on the GSE after 8 weeks compared to baseline.
8 weeks
Global Clinical Issues (GCI)
Time Frame: 8 weeks
Change of score on GCI after 8 weeks compared to baseline.
8 weeks
Circulating, cell-free DNA (cfDNA)
Time Frame: 8 weeks
Change of cfDNA concentrations after 8 weeks compared to baseline.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Collaborators

Department of Psychiatry and Psychotherapy, University Medical Center, Mainz

Investigators

  • Principal Investigator: Patrick Jung, PD Dr. habil., Department of Psychiatry and Psychotherapy, University Medical Center, Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXDEP_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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