An interventional study of Exogenous ketone supplementation and Matched placebo beverage in Postpartum Depression (PPD), sponsored by Ohio State University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Ohio State University · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of a 16-week, fully remote, multimodal intervention combining exogenous ketone supplementation (Qitone™) with group-mediated cognitive behavioral (GMCB) counseling with structured exercise for women diagnosed with postpartum depression (PPD). The study aims to determine whether integrating biochemical, behavioral, and physical activity strategies can improve depressive symptoms, metabolic health, and psychosocial functioning during the postpartum period.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 40 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Identify as female and are between 18-45 years of age. Are within 12 months postpartum following a live birth. Have a clinical diagnosis of Postpartum Depression (PPD) confirmed by a healthcare provider and/or an EPDS score ≥10 at screening. Are medically cleared by their healthcare provider for light-to-moderate physical activity. Are willing and able to participate in virtual group exercise sessions (2× weekly) and behavioral counseling sessions (1× weekly) for 16 weeks. Are willing to consume the study supplement (Qitone™ exogenous ketone or placebo) twice daily for the duration of the study. Have access to reliable internet and a device capable of participating in Zoom-based sessions. Are not currently following a ketogenic or low-carbohydrate diet. Are able and willing to complete daily glucose and ketone monitoring and wear a sleep/activity tracking ring. Are fluent in English and able to read and provide .
Exclusion Criteria:
Current pregnancy or planning to become pregnant during the study period. Breastfeeding exclusively if determined by their healthcare provider to be at risk for dietary modification or supplement use. Diagnosed with a severe psychiatric disorder (e.g., bipolar disorder, psychosis, schizophrenia) or current suicidal ideation requiring crisis intervention. History of seizure disorders, uncontrolled hypertension, or cardiovascular disease that would preclude participation in exercise. Current use of ketone supplements, GLP-1 receptor agonists, or weight loss medications. Known metabolic, renal, or hepatic disorders that may interfere with ketone metabolism or supplement safety. Participation in another interventional study within the past 30 days. Any condition that, in the judgment of the investigators, would make participation unsafe or compromise study integrity (e.g., inability to adhere to study schedule).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group-Mediated Cognitive Behavioral Intervention with exercise and ketone supplement
Dietary Supplement: Exogenous ketone supplementation · Behavioral: Group-Mediated Cognitive Behavioral Counseling · Behavioral: Structured Group Exercise
Group-Mediated Cognitive Behavioral Intervention with exercise and placebo supplement
Other: Matched placebo beverage · Behavioral: Group-Mediated Cognitive Behavioral Counseling · Behavioral: Structured Group Exercise
Participants will consume Qitone exogenous ketone supplement orally twice daily for 16 weeks. Supplements will be pre-packaged and labeled with identification codes to maintain blinding. Adherence will be monitored through self-report logs and returned packaging counts.
Also known as: Qitone
Participants will consume an inert placebo beverage orally twice daily for 16 weeks. The placebo will be matched to the Qitone supplement in appearance and taste. It will be pre-packaged and labeled with identification codes to maintain blinding. Adherence will be monitored through self-report logs and returned packaging counts.
Participants will attend one 30-45-minute virtual Group-Mediated Cognitive Behavioral counseling session per week for 16 weeks. Sessions will be led by trained behavioral specialists and emphasize group support, cognitive reframing, self-regulation, motivation, and adherence to exercise and nutrition recommendations. Content will progress through intensive, transition, and maintenance phases.
Also known as: GMCB
Participants will attend two 30-minute virtual group exercise sessions per week for 16 weeks. Sessions will combine resistance and interval-based training led by certified instructors. Exercise intensity and progression will be individualized based on perceived exertion and postpartum safety. Participants will also be encouraged to achieve at least 150 minutes of moderate-to-vigorous physical activity per week.
Change in Edinburgh Postnatal Depression Scale Total Score
Change in Edinburgh Postnatal Depression Scale (EPDS) total score from baseline to Week 16. The EPDS is a 10-item self-report questionnaire assessing depressive symptoms during the preceding seven days. Each item is scored from 0 to 3, yielding a total score of 0 to 30. Higher scores indicate greater depressive symptom severity. A decrease from baseline indicates improvement.
Time frame: Baseline (Week 0) and Week 16
Percent Change in Total Lean Mass
Percent change in total lean mass from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA).
Time frame: Baseline (Week 0) and Week 16
Percent Change in Total Fat Mass
Percent change in total fat mass from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA).
Time frame: Baseline (Week 0) and Week 16
Percent Change in Body Fat Percentage
Percent change in body fat percentage from baseline to Week 16, measured using dual-energy X-ray absorptiometry (DEXA).
Time frame: Baseline (Week 0) and Week 16
Percent Change in Body Weight
Percent change in measured body weight from baseline to Week 16.
Time frame: Baseline (Week 0) and Week 16
Percent Change in Body Mass Index
Percent change in body mass index (BMI) from baseline to Week 16. BMI is calculated as body weight in kilograms divided by height in meters squared.
Time frame: Baseline (Week 0) and Week 16
Percent Change in Waist Circumference
Percent change in measured waist circumference from baseline to Week 16.
Time frame: Baseline (Week 0) and Week 16
Percent Change in Hip Circumference
Percent change in measured hip circumference from baseline to Week 16.
Time frame: Baseline (Week 0) and Week 16
Percent Change in Fasting Blood Beta-Hydroxybutyrate Concentration
Percent change in fasting blood beta-hydroxybutyrate concentration from baseline to Week 16. Beta-hydroxybutyrate is measured to assess circulating ketone levels.
Time frame: Baseline (Week 0) and Week 16
Percent Change in Fasting Serum Glucose Concentration
Percent change in fasting serum glucose concentration from baseline to Week 16, measured using a validated commercial assay.
Time frame: Baseline (Week 0) and Week 16
Percent Change in Fasting Serum Insulin Concentration
Percent change in fasting serum insulin concentration from baseline to Week 16, measured using a validated commercial assay.
Time frame: Baseline (Week 0) and Week 16
Percent Change in Fasting Serum Cortisol Concentration
Percent change in fasting serum cortisol concentration from baseline to Week 16, measured using a validated commercial assay.
Time frame: Baseline (Week 0) and Week 16
Baseline (Week 0) and Week 16
Percent change in serum C-reactive protein (CRP) concentration from baseline to Week 16, measured using a validated commercial assay. CRP is assessed as a marker of inflammation.
Time frame: Baseline (Week 0) and Week 16
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — This is an early-stage pilot study focused on feasibility and exploratory outcomes. At this stage, individual participant data (IPD) will not be publicly shared until all analyses are complete and findings are published. De-identified aggregate data may be shared upon reasonable request following publication, in accordance with institutional and IRB policies. If a larger, follow-up trial is initiated, a formal data-sharing plan will be developed to align with NIH and ICMJE requirements.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2029, 41 months after the start.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 41 months is above that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.