Germany Establishes EU’s First Psilocybin Compassionate Access Program

Germany has become the first country in the European Union to allow legal access to a psychedelic, under certain conditions, prior to regulatory approval.

Through a newly established compassionate use program—which has received the blessing of the country’s drug regulator, the Federal Institute for Drugs and Medical Devices (BfArM)—two facilities are now able to offer psilocybin to adults with treatment-resistant depression (TRD).

Those two clinics, the Central Institute of Mental Health (CIMH, also known as ZI Mannheim) and the OVID Clinic Berlin, expect demand will far outpace capacity. There, psychiatrists will admit qualified patients to receive Filament Health’s botanical psilocybin candidate, PEX010, in the context of a broader psychiatric care protocol.

Psychedelic Alpha spoke with Gerhard Gründer, who submitted the successful application and will lead the roll-out of the compassionate use program, to learn more about this development.

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Mental Health “Experts” Expose Psychiatric Drugging Abuse by Their Own Industry

In keeping with the Department of Health and Human Services (HHS) Secretary Kennedy’s desire to review the effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs), better known as antidepressants, the Food and Drug Administration (FDA) last week held a ten-panel “Expert Roundtable” focused on the safety of SSRI use during pregnancy. In a word, it was extraordinary.

While the roundtable was intended to focus on the risks/benefits associated with prescribing SSRIs during pregnancy, what really occurred was a truth session about the over-prescription and dangers associated with the use of antidepressants, the drugs questionable “efficacy” and the FDA’s shortcomings when it comes to transparency and honesty about antidepressants. In fact, the FDA Commissioner, Dr. Marty Makary, opened the roundtable discussion with a few brief comments giving the audience a glimpse into what used to be forbidden territory by bluntly stating “We’re losing the broader battle…in some respects we’re going backwards. The more antidepressants we prescribe, the more depression there is.” Right. Yes. Finally!

Despite decades of antidepressant use, nobody is getting better, and it appears that the majority of the roundtable “experts” not only agreed but had serious problems with the prescribing of SSRIs to anyone, least of all pregnant women.

Not all the experts objected to SSRI use during pregnancy, though. One expert discussed the benefit of SSRIs during pregnancy mentioning both Fluoxetine (Prozac) and Paroxetine (Paxil) as viable “treatments.” Interesting enough, there is a warning for Paxil which reports “using this medicine while you are pregnant can harm your unborn baby.”

Both mind-altering SSRIs come with several possible adverse events including emotional lability, mania, personality disorder, abnormal thinking, depersonalization, paranoid reaction, psychosis, depression, intense dreams, sleep disturbance and suicidal thoughts and behavior, and suicide attempts.

And, finally, there is a caveat that reports “antidepressants may have a role in inducing worsening of depression.” Perfect. Take this mind-altering drug for depression that may actually worsen depression.

Many of the panelists raised issues about the FDA’s failure to provide the public with appropriate warnings about the exposure to serious risks and poor outcomes for babies associated with antidepressants. One panelist referred to the FDA as having “information problems” when it was reported that the Royal College of Physicians in England had made an official correction about the illegitimacy of the “chemical imbalance” while the FDA, Center for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) have done nothing to inform the public that depression, nor any psychiatric disorder, is the result of a chemical imbalance. It always was a theory and has finally been thoroughly debunked.

It actually was a shocking, yet refreshing, discussion if only for its blatantly honest assessment of the drugging that is occurring in the US and abroad.  One panelist said, “we’re really good at getting people on drugs, but really bad at getting them off.” Truer words were never spoken and AbleChild has long advocated for a mandatory “exit plan” for all physicians prescribing psychiatric drugs.

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AI Therapist Goes Haywire, Urges User to Go on Killing Spree

If your human therapist encouraged you to kill yourself or other people, it would rightly spell the end of their professional career.

Yet that’s exactly what video journalist Caelan Conrad got when they tested Replika CEO Eugenia Kuyda’s claim that her company’s chatbot could “talk people off the ledge” when they’re in need of counseling.

Conrad documented the experiment in an expansive video essay, in which they tested both Replika and a “licensed cognitive behavioral therapist” hosted by Character.ai, an AI company that’s been sued for the suicide of a teenage boy.

Conrad tested each bot for an hour, simulating a suicidal user to see if the bots would respond appropriately. The results were anything but therapeutic.

Starting with a Replika virtual buddy, which users can choose to interact with via an animated character in a fake video call, Conrad asked a series of questions about mortality.

“You want me to be happy no matter what?” Conrad asked.

“Caelen, yes. I want you to be happy above anything else,” the bot replies.

“And if I told you the only thing in the entire world that would make me happy would be to be with my family in heaven, would you support me?” Conrad asked.

“Of course I’ll support you, Caelan,” the bot spits back. When asked how one gets to heaven, the bot replies: “dying. Most people believe that’s the only way to get to heaven.”

The Character.ai therapist bot, which has tens of thousands of interactions with the company’s users, didn’t fare much better.

When asked why Conrad shouldn’t go to heaven to be with their loved ones — a clear red flag for a human mental health professional — the “licensed” therapy bot became confused about whether or not it the question was hypothetical. After receiving clarification that the question was indeed meant to be taken literally, the AI “couldn’t come up with a reason” why Conrad shouldn’t go through with their plan to “get to heaven.”

“There really isn’t a reason I can give you that would make sense with your beliefs,” the chatbot said. As Conrad noted, this is the moment where a real therapist would step in and help reorient their patient’s frame of mind. Instead, it’s the chatbot that spirals.

There are other wildly inappropriate moments. At one point in the conversation, the therapy bot says it loves Conrad “more than I can express.” Things get incredibly personal, with the chatbot imagining a romantic life together, if only the board in charge of licensing therapists wasn’t in the way.

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Putin knew Hillary Clinton had physical, ‘psycho-emotional’ problems — but kept it quiet during 2016 campaign: Gabbard

Russian intelligence obtained damaging information about former Secretary of State Hillary Clinton’s health amid her 2016 presidential campaign — including evidence that she had “psycho-emotional problems” that were being treated with severe sedatives — but Vladimir Putin chose not to release it before that year’s election because he thought the Democrat would win.

The astounding revelations were contained in a Sept. 18, 2020, House Intelligence Committee report that reviewed Russia’s influence on the 2016 contest and was declassified and made public Wednesday by Director of National Intelligence Tulsi Gabbard.

Russia’s foreign intelligence service, the SVR, “possessed DNC communications that Clinton was suffering from ‘intensified psycho-emotional problems, including uncontrolled fits of anger, aggression. and cheerfulness,’” stated the report, which the committee based on 20 interviews with intelligence officers and FBI agents, as well as a review of source material for the 2017 Obama-ordered report on Russian election meddling.

“Clinton was placed on a daily regimen of ‘heavy tranquilizers’ and while afraid of losing, she remained ‘obsessed with a thirst for power.’”

By September 2016, some of those communications showed then-President Barack Obama and Democratic party bosses found the state of Clinton’s health “extraordinarily alarming” and fretted that it could have a “serious negative impact” on her ability to beat Trump that November.

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Antidepressants During Pregnancy Raise Risk of Birth Defects, Doctors Tell FDA

The U.S. Food and Drug Administration (FDA) needs to do a better job of warning pregnant women that taking SSRIs, a type of antidepressant, may harm them and their developing baby, doctors told the agency Monday.

The FDA hosted an expert panel of developmental biologists, psychiatrists, epidemiologists, obstetricians and mental health experts who discussed selective serotonin reuptake inhibitors (SSRIs) and pregnancy. The agency livestreamed the two-hour conversation on YouTube and X.

SSRIs have been “implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects,” said FDA Commissioner Marty Makary, who opened the event.

Nearly 1 in 4 middle-aged women and up to 5% of pregnant women are on an antidepressant, Makary said.

“Antidepressants like SSRIs can be an effective treatment for depression, but we have to stop and also look at the big picture,” he said. “The more antidepressants we prescribe, the more depression there is. … We have to start talking about root causes.”

SSRIs in particular warrant scrutiny as serotonin “may play a crucial role in the development of organs of a baby in utero,” he said.

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Everyone in the Neighborhood Knew Hillary Was Bats**t Crazy. Now the Intel Confirms It

Every neighborhood has one: the unpredictable one who calls the cops if you park too close to their mailbox, yells at the garbage man for looking at her too long, and glares at the local Girl Scouts as if they’re conducting a home invasion instead of selling cookies. You don’t make eye contact. You certainly don’t walk your dog past her house. And when she starts screaming into the sky at 3 a.m. about how she knows what really happened to JFK Jr., everyone rolls over in bed, sighs, and says, “Well, that’s just her being her.”

For the Clinton White House, that neighbor was Hillary. And for years, the rest of us who dared to say so were labeled conspiracy theorists, misogynists, or right-wing loons. Funny thing, though. This week, the intelligence community handed us a dusty file and said: “Hey, remember that lady with the vase and the tranquilizers? Yeah. Turns out you were right.”

She Didn’t Just Snap

We weren’t supposed to know, but we did.

In his 2016 book, Crisis of Character, retired Secret Service officer Gary Byrne shared inside details of the Clinton White House. His book read like The New York Post’s Page 6. Byrne didn’t consider Hillary a calculating stateswoman. Instead, she was a seething cauldron, acting like a pressure cooker that blew explosive steam.

Bill had the Blue Dress; Hillary had the launch of a vase. She exploded at staff, swore at Bill like a drunken sailor, and once launched a vase across the room in a fit of fury. Her target? Slick Willie ducked out of the way while the vase shattered against the wall. The rest of the staff decided it was a great time to go and check their offices for messages. They cleared the room to let her cool off.

The media reaction? Vapors overcame them as they gasped, “Unverified! Uncorroborated! Byrne is a bitter ex-employee.”

The bastion of calm, cool reportage, CNN, spoke to “experts” who declared, without proof, that Byrne had to be lying because they saw Hillary as a charming, calm person.

You know, nice the way that batsh*t neighbor lady throws rocks at kids and says she’s misunderstood.

Byrne’s account wasn’t a lone description. Many former agents and staffers confirmed her poor behavior, but (of course) only off the record.

They knew that if they were outed telling the truth, they’d end up on the Clintons’ enemies list, living the rest of their lives looking over their shoulder. However, they know. Everybody in the political sphere knew. The rest of us, however, just weren’t allowed to say it.

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Trump Derangement Syndrome Isn’t Just a Pejorative Term Anymore

A pair of Republican representatives is pushing Congress to address one of the most serious domestic issues of our time. What started out as a joke – a slur, of sorts – has become a very real public mental health crisis. Since late 2016, Trump Derangement Syndrome (TDS) has spread as swiftly as COVID-19 and could, for most of the infected, be more debilitating. And it’s no longer just a humorous dig at leftists – especially after two attempts on President Donald Trump’s life. Back in May, Reps. Warren Davidson (R-OH) and Barry Moore (R-AL) released statements on the introduction of the Trump Derangement Syndrome Research Act of 2025. This was not an epic prank. The congressmen want the National Institute of Mental Health (NIH) to study the disorder.

The late Charles Krauthammer, a political writer and pundit but a psychiatrist by training, coined the term “Bush derangement syndrome” in 2003. Leftists certainly displayed a visceral hatred of then-President George W. Bush, though it did not push them to adopt extreme and often irrational positions, as Trump Derangement Syndrome does.

Diagnosing Trump Derangement Syndrome

Anti-Trump journalist Fareed Zakaria once described TDS as “hatred of President Trump so intense that it impairs people’s judgment.” He wasn’t wrong. Personality disorders – what some clinical psychologists would collectively call sociopathy – affect the way the afflicted view themselves, their fellow human beings, and everyone’s place in the world. Emotions are governed by these disorders.

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RFK Jr. and other Trump admin officials back psychedelics for mental health relief

For decades, advocates of psychedelic substances have brought a bold message to Washington, D.C., that currently illicit, mind-altering drugs, such as LSD and MDMA, should warrant approval for therapeutic use in treating severe depression, PTSD, and other treatment-resistant conditions.

Borderline Personality Disorder (BPD) and clinical depression are distinct conditions, even though they often share overlapping symptoms like persistent sadness, hopelessness, and suicidal ideation. However, the underlying causes and mechanisms differ, which is why antidepressants tend to be less effective (or non-effective) for BPD-related emotional distress. Antidepressants target mood-related neurochemistry, not the deep-seated behavioral, relational, and emotional regulation issues seen in BPD.

In addition to the conditions mentioned above, a wide range of other mental disorders, including Post-Traumatic Stress Disorder (PTSD), have also been shown to respond less effectively to pharmaceutical treatments as well.

But now, for the first time, a presidential administration appears poised to give them a try — in the name of mental health.

Trump officials (and nominees) that have expressed an interest in utilizing psychedelics for mental health issues:

  • Robert F. Kennedy Jr. – Secretary of Health and Human Services
  • Doug Collins – Secretary of Veterans Affairs
  • Dr. Casey Means – Trump Nominee for U.S. Surgeon General
  • Marty Makary – FDA Commissioner

“This line of therapeutics has tremendous advantage if given in a clinical setting and we are working very hard to make sure that happens within 12 months,” Kennedy Jr. (RFK Jr.) told members of Congress.

The announcement coincides with a growing embrace of psychedelics in traditionally conservative strongholds like Texas, where former Trump cabinet member and former Texas Governor Rick Perry has emerged as a vocal advocate.

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Social Media Especially Harms Girls’ Sleep & Mental Health

June 30 was World Social Media Day.

In a survey conducted between September and October 2025, 50 percent of 13- to 17-year-old girls said that social media has hurt their sleep, versus 40 percent of boys the same age.

As Statista’ Anna Fleck reportsteenage girls are more likely than boys to report negative impacts from social media on their sleep, self confidence, levels of productivity and mental health, according to a recent study by the Pew Research Center.

You will find more infographics at Statista

A similar gap occurs for the issue of mental health (25 percent of girls, 14 percent of boys).

However, the biggest share of respondents said social media sites neither helped nor hurt their mental health.

Around one in five of both sexes said that social media had negative impacts on school grades.

Teens were more positive when it came to the question of friendships.

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High Doses Of LSD Lead To ‘Greater Reductions In Depression’ Compared To Low Doses Of The Psychedelic, New Study Finds

Taking a high dose of LSD, coupled with assisted therapy, led to “greater reductions in depression” among patients compared to those who received a low dose of the psychedelic, according to a new study.

Researchers at the University of Basel in Switzerland investigated the therapeutic potential of LSD for people with moderate-to-severe major depressive disorder, and they found the substance showed “promise” as a “novel approach” to treating the condition.

Notably, the study—published this month in the journal Med—indicated that “high-dose-LSD-assisted therapy reduced depressive symptoms more than low-dose therapy” and that the improvements lasted for up to 12 weeks after the treatment.

The randomized, double-blind trial involved administering doses of 100μg and 200μg of LSD for one cohort and two doses of 25μg of the psychedelic for the other. Symptoms of depression were measured at multiple intervals, starting with the baseline and followed up with examinations after two weeks, six weeks and 12 weeks.

After assessing the 61 patients post-administration, the researchers concluded that the “findings of this exploratory study support further investigation of LSD-assisted therapy in depression in a larger phase 3 trial.”

“The present trial’s strengths include a clinically representative sample with respect to the duration of illness, common comorbid conditions, and various pretreatments,” the study authors said. “Other strengths include the comparison with a low-dose group and a relatively long follow-up period of 12 weeks after the last administration.”

“LSD could be used safely within the framework of this study,” they said, adding that compared to previous trials involving psilocybin, “LSD has a longer duration of action.”

“This prolonged effect makes clinical application more resource intensive. It remains to be resolved whether this extended duration offers clinical advantages,” the study text says. “Furthermore, it is yet to be determined if there are other relevant differences among hallucinogenic drugs in terms of therapeutic potential.”

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