Probiotics to Treat "Inflammatory Depression"
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03660280|
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Dietary Supplement: Probiotics Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Intervention will be add-on specific probiotic to ongoing treatment with antidepressant medication or Cognitive Behavioral Therapy (CBT). Subjects will be randomized to placebo or probiotic. To assure a balanced subject recruitment, block randomization within strata (ongoing treatment with CBT, antidepressant or both) will be performed. Blood sampling and symptom rating scales will be completed at baseline, at weeks 4 and 8 (end of study). Feces will be collected at baseline and end of study. Biomarkers (from baseline, week 4 and week 8) will be analyzed after the study. Subjects will be recruited from outpatient or inpatient settings, Psychiatry Skåne or primary care clinics in Skåne, Sweden. Subjects will be recruited via clinical referrals, but also via ads.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Probiotics to Treat "Inflammatory Depression" - a Randomized Controlled Trial|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Dietary Supplement: Probiotics
Specific probiotic lactobacilli (added to stabilized ongoing treatment)
|Placebo Comparator: Placebo||
- Montgomery-Åsberg Depression Rating Scale (interview version) [ Time Frame: 8 weeks ]Decrease in depressive symtoms indicated by lower total score on mentioned scale, with 10 items, ranging from 0-60, a higher score indicating increased severity
- "Inflammatory depressive symptoms" [ Time Frame: 8 weeks ]Total composite score of the following items from the Patient Health Questionnaire (PHQ-9): item 3 (sleep problems), item 4 (lack of energy), and item 5 (appetite disturbance)
- Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) [ Time Frame: 8 weeks ]Total Composite score indicate severity of gastrointestinal symtoms, ranging from 0-78
- Dimensional Anhedonia Rating Scale (DARS) [ Time Frame: 8 weeks ]Total Composite score of 17 items, measuring different hedonic domains.
- WHO Disability Assessment Schedule (WHODAS) [ Time Frame: 8 weeks ]Total Composite score of 36 items, measuring Health and disability within 6 different domains, ranging from 0-144.
- Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 8 weeks ]Total Composite score of 7 items, measuring anxiety symtoms, ranging from 0-21.
- Insomnia Severity Index (ISI) [ Time Frame: 8 weeks ]Total Composite score of 7 items, ranging from 0-28
- Fatigue Severity Scale (FSS) [ Time Frame: 8 weeks ]Total Composite score of 9 items, measuring severity of fatigue, ranging from 1-63
- Wechsler Adult Intelligence Scale (WAIS-IV) [ Time Frame: 8 weeks ]Two Composite scores of two tests measuring cognitive functioning. Symbol search, ranging from 0-60 and Digit symbol coding test ranging from 0-135.
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): NCT03660280
|Contact: Daniel Lindqvist, PhDemail@example.com|
|Contact: Gustav Söderberg, MD|
|Psychiatry Clinic, Lund, Region Skåne||Recruiting|
|Lund, Sweden, 22358|
|Contact: Daniel Lindqvist 733547441 firstname.lastname@example.org|
|Principal Investigator:||Daniel Lindqvist, PhD||Region Skane|