IPT + Ketamine for Postpartum Depression

(SMILES Trial)

No longer recruiting at 1 trial location

Overseen By Haley Bernstein

Age: Any Age

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Washington University School of Medicine

Disqualifiers: Seizure disorder, Severe head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help low-income women improve their mood after a cesarean section by combining therapy and ketamine. Participants will engage in interpersonal therapy sessions and receive two ketamine injections within the first four days postpartum. Researchers aim to determine the feasibility of recruiting participants, delivering the treatment, and collecting data on its effectiveness. Women with depressive symptoms who are scheduled for or have recently undergone a cesarean delivery may be suitable for this trial. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that interpersonal psychotherapy (IPT) effectively treats postpartum depression, helping many new mothers feel better and making it a safe option to consider.

Research indicates that ketamine can also reduce postpartum depression, particularly after a cesarean delivery. However, safety results from animal studies have been mixed. In humans, ketamine is generally well-tolerated, but like any treatment, it can have side effects.

Both treatments have undergone safety studies in humans. IPT has a strong record of safety and effectiveness. Ketamine is also considered safe, especially in controlled settings, but discussing potential risks with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Interpersonal Psychotherapy (IPT) combined with ketamine for postpartum depression because this approach offers a novel mechanism of action and rapid relief. While standard treatments like antidepressants and therapy can take weeks to show effects, ketamine has the potential to alleviate symptoms in just days by acting on the brain's glutamate system. Additionally, the use of subcutaneous ketamine allows for controlled dosing in the critical first days after childbirth. This combination aims to provide fast and effective relief, addressing both the emotional and biological aspects of postpartum depression.

What evidence suggests that IPT and ketamine might be effective for postpartum depression?

Studies have shown that Interpersonal Psychotherapy (IPT) effectively treats postpartum depression by reducing depression and lifting mood. Women who received IPT were much less likely to remain depressed. Research has also shown that ketamine effectively treats postpartum depression, preventing depression after childbirth and outperforming some traditional antidepressants. In this trial, participants will receive a combination of IPT and ketamine, which together can greatly improve mental health for women after giving birth. ^{1 3 4 6 7}

Who Is on the Research Team?

David Monks, MBCHB

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for English-speaking, low-income women who are 20-32 weeks pregnant and scheduled for a cesarean delivery or within 48 hours post-cesarean. They must be experiencing depressive symptoms (EPDS > 10). It's not open to those with ketamine allergies, seizure disorders, metal implants near the brain, cardiac devices, or severe head trauma.

Inclusion Criteria

You are from a socio-economically disadvantaged background, requiring public assistance.

You are 20 - 32 weeks pregnant, have a score of 10 or higher on the EPDS test for depressive symptoms, and are either scheduled to undergo a cesarean delivery within 48 hours or have recently had an unscheduled (or scheduled) cesarean delivery.

Exclusion Criteria

You have had a serious head injury or a neurological disorder that greatly increases your risk of having seizures, as determined by the study doctor.

I have a history of seizures due to a brain disorder or lesion.

Contraindications for TMS including the presence of metallic objects within 30 cm of the TMS coil, intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; presence of intracardiac lines, defibrillators or a cardiac pacemaker and unable to assess safety; presence of implanted electronic devices that control physiologic functions and unable to assess safety

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Participants receive two subcutaneous ketamine injections approximately 24 hours apart, and complete five sessions of interpersonal therapy

4 days

Multiple visits for ketamine injections and therapy sessions

Follow-up

Participants are monitored for mood and brain activity assessments over the first 12 postpartum weeks

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Interpersonal Psychotherapy (IPT)
• Ketamine

Trial Overview The Perinatal SMILES intervention combines interpersonal therapy with two doses of subcutaneous ketamine after cesarean birth. The study will assess its feasibility and effects on mood through EEGs before/after treatment and mood assessments over the first three months postpartum.

How Is the Trial Designed?

Group I: Intervention Interpersonal psychotherapy plus ketamine Experimental Treatment 2 Interventions

Five sessions of interpersonal psychotherapy (IPT) and pre-, and post-, ketamine sessions b) Two doses of subcutaneous (SC) ketamine in the first 4 post-cesarean days

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11074869/

Efficacy of interpersonal psychotherapy for postpartum ... These findings suggest that IPT is an efficacious treatment for postpartum depression. Interpersonal psychotherapy reduced depressive symptoms and improved ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11032640/

Effectiveness of interpersonal psychotherapy in comparison to ... Interpersonal therapy versus antidepressant medication for treatment of PPD and anxiety among women with HIV in Zambia: a randomized feasibility ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/481669

Efficacy of Interpersonal Psychotherapy for Postpartum ... Conclusions These findings suggest that IPT is an efficacious treatment for postpartum depression. Interpersonal psychotherapy reduced depressive symptoms and ...

5. womensmentalhealth.org womensmentalhealth.org/posts/phone-therapy-ppd/

Telephone-Based Interpersonal Therapy for PPD is Effective Women receiving IPT were 4.5 times less likely to be clinically depressed. According to scores on the Edinburgh Postnatal Depression Scale (EPDS) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4141636/

Interpersonal Psychotherapy for Postpartum Depression Perinatal depression is prevalent and has a great impact on both mother and infant. There are empirically validated treatments for both postpartum ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10116385/

Effect of Brief Interpersonal Therapy on Depression During ... This randomized clinical trial evaluates depression improvement (symptoms and diagnosis) among pregnant individuals from diverse backgrounds