Clinical trial NCT02874833: Exercise for Depression
Official title: The Efficacy of Exercise in Depressive Episodes of Unipolar Depression and Bipolar Affective Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Unipolar
Bipolar Disorder
Keywords: Depression
Unipolar depression
Bipolar affective disorder
Exercise
Internet-based intervention
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Department of Psychiatry and Psychotherapy, University Medical Center, Mainz
First posted: 2016-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - clinical rating-16 (QIDS C-16)
timeFrame: 8 weeks
measure: Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - self-report-16 (QIDS SR-16)
timeFrame: 8 weeks
Secondary outcomes:
measure: Adherence of internet-based concept
timeFrame: 8 weeks
measure: Placebo effect of exercise (QIDS-SR16)
timeFrame: 8-10 days
measure: Placebo effect of exercise (QIDS-C16)
timeFrame: 8-10 days
measure: Peak oxygen uptake (VO2peak)
timeFrame: 8 weeks
measure: Lactate threshold
timeFrame: 8 weeks
measure: Short form 36 (SF36) health survey questionnaire
timeFrame: 8 weeks
measure: General self efficacy questionnaire (GSE)
timeFrame: 8 weeks
measure: Global Clinical Issues (GCI)
timeFrame: 8 weeks
measure: Circulating, cell-free DNA (cfDNA)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Psychiatry and Psychotherapy, University Medical Center, Mainz
state: Rhineland-Palatinate
city: Mainz
country: Germany
facility: Department of Sports Medicine, Johannes Gutenberg University, Mainz
state: Rhineland-Palatinate
Study officials:
affiliation: Department of Psychiatry and Psychotherapy, University Medical Center, Mainz
name: Patrick Jung, PD Dr. habil.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.
citation: Malykhin NV, Coupland NJ. Hippocampal neuroplasticity in major depressive disorder. Neuroscience. 2015 Nov 19;309:200-13. doi: 10.1016/j.neuroscience.2015.04.047. Epub 2015 Apr 28.
citation: van Praag H, Shubert T, Zhao C, Gage FH. Exercise enhances learning and hippocampal neurogenesis in aged mice. J Neurosci. 2005 Sep 21;25(38):8680-5. doi: 10.1523/JNEUROSCI.1731-05.2005.
citation: Yau GS, Lee JW, Woo TT, Wong RL, Wong IY. Central Macular Thickness in Children with Myopia, Emmetropia, and Hyperopia: An Optical Coherence Tomography Study. Biomed Res Int. 2015;2015:847694. doi: 10.1155/2015/847694. Epub 2015 Jun 8.
citation: Haller N, Lorenz S, Pfirrmann D, Koch C, Lieb K, Dettweiler U, Simon P, Jung P. Individualized Web-Based Exercise for the Treatment of Depression: Randomized Controlled Trial. JMIR Ment Health. 2018 Oct 12;5(4):e10698. doi: 10.2196/10698.
citation: Pfirrmann D, Haller N, Huber Y, Jung P, Lieb K, Gockel I, Poplawska K, Schattenberg JM, Simon P. Applicability of a Web-Based, Individualized Exercise Intervention in Patients With Liver Disease, Cystic Fibrosis, Esophageal Cancer, and Psychiatric Disorders: Process Evaluation of 4 Ongoing Clinical Trials. JMIR Res Protoc. 2018 May 22;7(5):e106. doi: 10.2196/resprot.8607.