CLEVELAND, Ohio — It’s common for women to feel blue briefly after giving birth. But a severe mood problem could be postpartum depression, which can lead to suicide in rare cases.
Could a synthetic drug similar to magic mushrooms, or psilocybin, treat this mental health disorder? The Cleveland Clinic is one of 25 U.S. sites participating in a study to investigate this question.
The idea isn’t to send moms on a psychedelic trip, but to rewire their brains to relieve low moods, said Dr. Brian Barnett, a physician with the Center for Adult Behavioral Health at Cleveland Clinic – Lutheran Hospital. He is running the Clinic’s study, and is co-director of the hospital’s Treatment-Resistant Depression Clinic.
The Clinic’s Phase 2 clinical trial will see if people who take a synthetic psychedelic drug called RE104 feel less depressed up to four weeks after treatment, he said.
RE104 affects serotonin receptors in the brain. It differs from natural psilocybin — the hallucinogenic compound found in magic mushrooms — because its consciousness-altering effects are of shorter duration.
“Potentially, if this was approved by the FDA, that (short-acting characteristic) would make it easier to give to patients,” Barnett said.
The Clinic currently is enrolling study participants who are up to 15 months after giving birth, are not breastfeeding and have postpartum depression.
The study had not found any participants as of late April, but the recruitment period will be extended until the study fills.
Anyone interested in joining the study, based at Clinic Lutheran Hospital, can call 216-425-7426 or email [email protected].
New treatments for postpartum depression are being sought because cases are on the rise across the United States.
A new study published in JAMA found a significant rise in postpartum depression diagnosis rates across all racial and ethnic groups in recent years. The rates of cases doubled, from 9.4% in 2010 to 19% in 2021.
Typically, women are prescribed the drug Zoloft for postpartum depression, but many don’t want to take a daily medication, Barnett said.
In the Clinic study of RE104, participants will receive a single dose of this drug, administered at Clinic Lutheran Hospital. They will be monitored for several hours while resting in a cozy room — decorated with cushioned chairs, a rug and pillows in soothing blues and taupes —set up especially for people taking psychedelics as part of clinical trials.
After taking RE104, study participants may feel euphoric, or experience altered perceptions such as brighter colors or hallucinations, Barnett said. Because psychedelic drugs tend to increase blood pressure and heart rate, study participants’ vital signs will be monitored.
Patients will make about 11 visits to Lutheran over a six-week period for the study, both before and after taking the drug.
A separate study is being conducted to find out if RE104 passes into breast milk. Until that data is analyzed, the Food and Drug Administration requires that women who sign up for the study aren’t breastfeeding, he said.
Medical uses for psilocybin are explored
Although psilocybin and lysergic acid diethylamide (LSD) are illegal in most places across the United States, attitudes are changing as researchers investigate if these drugs can be used safely to help treat conditions such as depression, post-traumatic stress disorder, addiction, pain and neurodegenerative disorders, according to the National Institutes of Health.
Psilocybin use has sharply increased since 2019, especially among Americans seeking to self-treat mental health conditions, according to a recent study published in the Annals of Internal Medicine.
A small 2021 survey of more than 7,000 people found that about 7% — or about 500 people — said they had used psilocybin mushrooms in the past year, according to the National Institutes of Health.
And recently, Iowa lawmakers advanced legislation that would legalize the use of psilocybin for psychiatric treatment through a program similar to how the state handles medical cannabis. The legislation must undergo further consideration.
The drug has been decriminalized in some cities, including Denver and Detroit.
Although there is stigma attached to the use of psychedelics, Barnett believes the drugs can be controlled in a medical setting and studied to learn if they can become treatment options for patients with behavioral health issues that don’t respond to conventional treatments.
“The patients I see are suffering tremendously,” he said. “They’re often willing to try anything to help with these conditions that they’ve had for years or decades.”
In 2023, Barnett led the Clinic’s participation in a national study looking at the possible use of LSD to treat severe anxiety. While data from that study has not yet been published, the results were promising,
Three months after patients received a single dose of 100 micrograms of LSD, about half no longer had anxiety disorder.
“We have never seen anything that effective,” Barnett said. “Psychedelics are consistently showing now that they can be helpful for patients where other treatments aren’t working.”
How psilocybin affects the brain, mood
Psilocybin is part of a group of drugs called psychedelics—or hallucinogens—that can cause users to hallucinate or experience reality in a different way, according to the National Institutes of Health. Research suggests psilocybin is not addictive, NIH said.
Both synthetic RE104 and natural psychedelics make the brain more malleable and open to learning new behaviors, Barnett said.
Researchers also think that psychedelics affect the brain’s default mode network, a part of the brain that is activated when people think about themselves or their problems.
Past studies have found the network is overactive in people with depression and other forms of mental illness, Barnett said.
Psychedelics appear to reset the network by turning it off for a brief period. When it reactivates, it’s in a less rigid state, he said.
“The default mode network is overactive because they’re ruminating on their own problems over and over, and can’t get out of that thought pattern,” Barnett said.
Julie Washington covers healthcare for cleveland.com. Read previous stories at this link.
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