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Exercise for Depression (EXDEP)

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ClinicalTrials.gov Identifier: NCT02874833
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Department of Psychiatry and Psychotherapy, University Medical Center, Mainz
Information provided by (Responsible Party):
Prof. Dr. Dr. Perikles Simon, Johannes Gutenberg University Mainz

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Depression, Unipolar Bipolar Disorder Other: Exercise Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Exercise in Depressive Episodes of Unipolar Depression and Bipolar Affective Disorders
Actual Study Start Date : July 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Lactate threshold [ Time Frame: 8 weeks ]
    Change of lactate threshold using the baseline +1.5 mmol model after 8 weeks compared to baseline.

  6. Short form 36 (SF36) health survey questionnaire [ Time Frame: 8 weeks ]
    Change of score on the SF-36 after 8 weeks compared to baseline.

  7. General self efficacy questionnaire (GSE) [ Time Frame: 8 weeks ]
    Change of score on the GSE after 8 weeks compared to baseline.

  8. Global Clinical Issues (GCI) [ Time Frame: 8 weeks ]
    Change of score on GCI after 8 weeks compared to baseline.

  9. Circulating, cell-free DNA (cfDNA) [ Time Frame: 8 weeks ]
    Change of cfDNA concentrations after 8 weeks compared to baseline.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874833


Locations
Germany
Department of Psychiatry and Psychotherapy, University Medical Center, Mainz
Mainz, Rhineland-Palatinate, Germany, 55099
Department of Sports Medicine, Johannes Gutenberg University, Mainz
Mainz, Rhineland-Palatinate, Germany, 55099
Sponsors and Collaborators
Johannes Gutenberg University Mainz
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Dr. Perikles Simon, Professor for Sports Medicine MD PHD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02874833     History of Changes
Other Study ID Numbers: EXDEP_1
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by Prof. Dr. Dr. Perikles Simon, Johannes Gutenberg University Mainz:
Depression
Unipolar depression
Bipolar affective disorder
Exercise
Internet-based intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Mood Disorders
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders