Exercise for Depression

NCT02874833 | Completed

• 1 other identifier: EXDEP_1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Depression, Unipolar; Bipolar Disorder

Keywords

Depression; Unipolar depression; Bipolar affective disorder; Exercise; Internet-based intervention

Outcome Measures

Primary Outcomes (2)

• Severity of depressive symptoms - Quick Inventory of Depressive Symptomatology - clinical rating-16 (QIDS C-16)

  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)

  Change of Score on the QIDS SR-16 after 8 weeks compared to baseline.

  8 weeks

Secondary Outcomes (9)

• Adherence of internet-based concept

  8 weeks

• Placebo effect of exercise (QIDS-SR16)

  8-10 days

• Placebo effect of exercise (QIDS-C16)

  8-10 days

• Peak oxygen uptake (VO2peak)

  8 weeks

• Lactate threshold

  8 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Treatment as usual group

NO INTERVENTION

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

Interventions

Exercise 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.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Aged 18 to 65 years old, inclusive, at the time of informed consent.
• Montral Cognitive Assessment (MoCA) \> 26 to exclude cognitive impairment.
• 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.
• QIDS scores \> 5

You may not qualify if:

• Use of antidepressive medications or benzodiazepines at doses that have not been stable for at least 6 weeks prior to Screening
• Psychotherapy that started less than 8 weeks prior to Screening
• Any clinically significant psychiatric illness other than major depression or bipolar affective disorder
• Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
• Any uncontrolled medical or neurological/neurodegenerative condition that, in the opinion of the Investigator, might impair treatment compliance and adherence
• 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
• Clinically significant 12-lead ECG abnormalities, as determined by the Investigator
• Uncontrolled hypertension defined as: average of 3 systolic blood pressure \[SBP\]/diastolic blood pressure \[DBP\] readings \> 165/100 mmHg at Screening
• 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.
• History of seizure within 2 years prior to Screening.
• 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
• Clinically significant systemic illness or serious infection (e.g., pneumonia, septicemia) within 30 days prior to or during Screening
• History of human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Department of Psychiatry and Psychotherapy, University Medical Center, Mainz: collaborator

Study Sites (2)

Department of Psychiatry and Psychotherapy, University Medical Center, Mainz

Mainz, Rhineland-Palatinate, 55099, Germany

Location

Department of Sports Medicine, Johannes Gutenberg University, Mainz

Mainz, Rhineland-Palatinate, 55099, Germany

Location

Related Publications (6)

• 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.

  PMID: 24026850 BACKGROUND

• 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.

  PMID: 25934030 BACKGROUND

• 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.

  PMID: 16177036 BACKGROUND

• 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.

  PMID: 26167504 BACKGROUND

• 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.

  PMID: 30314962 DERIVED

• 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.

  PMID: 29789277 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder; Depression; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Patrick Jung, PD Dr. habil.

  Department of Psychiatry and Psychotherapy, University Medical Center, Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for Sports Medicine MD PHD

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 22, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

DE (2)