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Antidepressants Worsen Sexual Dysfunction and Depression? Megan Brooks October 20, 2016 Currently available antidepressants may aggravate sexual dysfunction and make depression worse, a new survey of US adults with major depressive disorder (MDD) suggests. "This survey provides a new window into the lives of those trying to manage and live with major depressive disorder and paints a comprehensive picture of the consequences of antidepressant treatments that don't also address sexual dysfunction," Anita H. Clayton, MD, professor and chair of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine in Charlottesville, said in a statement. Roughly 1000 US adults currently receiving antidepressant drug therapy for MDD participated in the Sexual Symptoms and Side Effects in Depression (SEXSED) survey, conducted online between September 28 and October 5, 2016. The vast majority (88%) of respondents reported a loss of sexual desire, satisfaction, or sexual function. More than two thirds (68%) first experienced sexual problems as a symptom of their depression, and 17% first experienced sexual problems only after starting antidepressants. Of those reporting sexual dysfunction, more than half (55%) saw no improvement or suffered further decline in sexual function since starting their current antidepressant treatment. Nearly three quarters (73%) of those with sexual dysfunction reported that it made depression worse. The survey was conducted by independent market research consultancy Wakefield Research and was commissioned by Fabre-Kramer Pharmaceuticals, the developer of gepirone extended-release (Travivo), a still experimental and somewhat controversial antidepressant that has a unique mechanism of action that may avert the sexual side effects of currently available antidepressants, such as selective serotonin reuptake inhibitors (SSRIs). Sexual side effects of antidepressants are a "significant concern for many patients," Dr Clayton noted in an interview with Medscape Medical News. "There have been any number of studies now showing that SSRIs can contribute to significant sexual dysfunction in multiple areas, including desire, arousal, and orgasmic function," she said. Gepirone "doesn't have serotonin reuptake inhibitory effects at all. It works at the serotonin 5-HT1A receptor," Dr Clayton explained. "There are some antidepressants on the market that also have a 5-HT1A effect, but they also have serotonin reuptake inhibitory effects. So if gepirone were approved, it would be the first drug like this for depression. It's been a long and drawn out process to approval, but I think it is moving forward," she said. Rocky Regulatory Road As reported previously by Medscape Medical News, in December 2015, a US Food and Drug Administration (FDA) advisory committee voted against approving gepirone (9 to 4), concluding that the available data did not support its approval. But the company appealed the decision, and in March of this year, the FDA Office of New Drugs notified the company that it had subsequently concluded that gepirone does demonstrate evidence of effectiveness in the short-term treatment of MDD. "This decision overturns FDA's previous position and resolves an outstanding deficiency impeding approval of Travivo," the company said in a news release at the time. But Natalie Compagni Portis, PsyD, MFT, who was a patient representative on the FDA advisory panel in 2015, remains unconvinced. There remains a "significant lack of evidence that gepirone performs well" in the treatment of MDD, she told Medscape Medical News. "It did not perform better than placebo or better than other active comparators in most of the trials. Post hoc analysis did show limited benefit in a few trials, but the endpoints had been changed in the post hoc analysis," she noted. "Furthermore, reduced risks [of sexual dysfunction] in light of ineffective treatment are irrelevant," Dr Portis said. "Sexual dysfunction is of meaningful and significant concern to patients weighing the cost/benefit balance, but benefit is primary. Without significant benefit with regard to the depression, the sexual side effects are not meaningful," she said. "I will say, though, that when considering taking antidepressants, patients do express concern about sexual side effects, and it is a real deterrent for some." Dr Portis added that she is "disappointed to hear that FDA has gone against the review panel's recommendations, though this is not without precedent." She said she stands by her comments to Medscape and at the review meeting. For now, said Dr Clayton, ways to manage sexual side effects of current antidepressants vary and usually depend on the individual. "Some people just want to wait and watch it, and maybe for about 5% to 10% of people, sexual function will get better over 4 to 6 months. That's a pretty small likelihood of being effective," she pointed out. "We do try to change the medication in some cases. For someone who has started on an antidepressant and it worked for them but they had sexual dysfunction, it's generally pretty easy to change them to another medication. But for people who have not responded to any number of medications and are finally on something that is helpful, then they may want to have something added in to try to counteract the sexual side effects," Dr Clayton said. Dr Clayton has financial relationships with Fabre-Kramer Pharmaceuticals, Takeda, Palatin Technologies, S1 Biopharma, and other pharmaceutical companies. Dr Portis has disclosed no relevant financial relationships. http://www.medscape.com/viewarticle/870660?src=wnl_edit_tpal
Research repeatedly shows that antidepressants give little benefit – but serious side effects. Yet millions who take them regard them as lifesavers. Markie Robson-Scott reports on the controversy that is dividing psychiatrists Tuesday, 25 October 2011 http://www.independe...rk-2375337.html When my American friend Bill, who'd been on SSRI antidepressants for 22 years (Prozac, followed by Paxil, Lexapro, then Celexa), read a two-part article by Dr Marcia Angell in The New York Review of Books recently about the crisis in psychiatry and the inefficacy of antidepressants, he stopped taking his meds (tapering off gradually, monitored by his doctor). "The article brought on enough doubt to push me over," he said. Since then, his moods have become more volatile – more anger, more emotion, such as crying at the end of the last Harry Potter film (he's in his 50s). But he's got his libido back after years of "muffled response" and that seems a worthwhile trade-off. Instead of listening to Prozac, have we been listening to placebo all along? Research repeatedly appears to show that: antidepressants are little more than placebos, with very little therapeutic benefit but serious side-effects (70 per cent of people on Celexa and Paxil report sexual dysfunction, and in some, it carries on even when they stop taking the pills). The theory of chemical imbalance as a cause of depression is an unproven hypothesis; and doctors are prescribing the drugs mainly because of the "juggernaut of pharmaceutical promotion", as the US psychiatrist Dr Daniel Carlat calls it. It's not surprising there's a US media furore – about 10 per cent of Americans over the age of six take antidepressants. In the UK, prescriptions for the drugs went up 43 per cent in the last four years to 23 million a year. Professor Irving Kirsch, associate director of the programme in placebo studies at Harvard Medical School and author of The Emperor's New Drugs: Exploding the Antidepressant Myth, says the theory of chemical imbalance – that there is not enough serotonin, norepinephrine and/or dopamine in the brain synapses of depressed people – doesn't fit the data (lowering serotonin levels in healthy patients has no impact on their moods). Chemical imbalance is a myth, he says. It follows that the idea that "antidepressants can cure depression chemically is simply wrong". His meta-analysis of 38 clinical studies – 40 per cent of which had been withheld from publication because drug companies didn't like the results – involving more than 3,000 depressed patients on SSRIs shows that only 25 per cent of the benefit of antidepressant treatment was due to the drugs and that 50 per cent was a placebo effect. "In other words, the placebo effect was twice as large as the drug effect," though the placebo response was lower in the severely depressed. This is not quite as damning as it sounds: placebos are extraordinarily powerful and can be "as strong as potent medications". Placebo response is specific: placebo morphine eases pain, placebo antidepressants relieve depression. It's a question of expectancy and conditioning: if you expect to feel better, you will, even if you're getting negative side effects, because side effects, Kirsch says, convince people that they've been given a potent drug. Psychotherapy boosts the placebo effect and is "significantly more effective than medication" for all levels of depression, he says. Antidepressants should only be used "as a last resort and only for the most severely depressed". Of course, not everyone agrees. Ian Anderson, Professor at psychiatry at the University of Manchester, who is to debate whether "antidepressants are useful in the treatment of depression" with Kirsch at a conference in Turkey next month, thinks we're in danger of throwing the baby out with the bathwater when we say antidepressants are rubbish. Antidepressants are part of a doctor's toolbox, though probably most useful for the most depressed; some people don't take to talking therapies; it's not an either/or situation, he says. Professor Allan Young, chair of psychiatry at Imperial College London, agrees. "Depression is such a huge category of illness – there are multiple types, and each type responds differently." Of course, the brain and the body are inextricably linked, he says, and placebo effects are greater in the less-severely ill. To make things more complicated, there's the nocebo effect. If you expect to feel bad when you come off antidepressants, you will, because "we tend to notice random small negative changes and interpret them as evidence that we are in fact getting worse", Kirsch says. Lucy, who was suicidal, took Cipramil (Celexa in the US) on and off for 10 years. She says the drug "gave me back myself, it was like a ray of light shining through fog", but the side effects – nausea and lost libido among others – forced her off it. Then "it was like a clock ticking, a twitch in the back of my mind. I lived in fear of the depression coming back. The only thing that kept me alive was knowing the pills were there. But was it because I believed I was a depressive so when I had the negative feelings I panicked?" For Judy, lofepramine, a tricyclic, worked well. "First I was given Prozac, which gave me huge anxiety, like a bad trip, and made me horribly aware of all my nerve-endings. But lofepramine worked from the first day. When I took it in the morning I'd get a chemical lift, like a switch being turned on: it was a fabulous rush of joy." She stopped taking it after six months. Several months later, she felt low, though not depressed – "I feel depression like a stone in my solar plexus, and it wasn't like that. But still I thought it would be nice to have that short-cut to happiness, so I took a lofepramine and it had no effect whatsoever – because I wasn't really depressed. So to me the placebo theory makes no sense." Neither does it to Hannah, who took Prozac for 10 years and says "it was absolutely fantastic and saved my life". Daniel Carlat, a psychiatrist in Boston and author of Unhinged: The Trouble with Psychiatry – A Doctor's Revelations about a Profession in Crisis says that prescribing is a hit-and-miss affair. "Unfortunately we know a good bit less about what we are doing than you might think," he writes. "When I find myself using phrases like 'chemical imbalance' and 'serotonin deficiency', it is usually because I'm trying to convince a reluctant patient to take a medication. Using these words makes their illness seem more biological, taking some of the stigma away." Most lay people, he says, don't realise how little shrinks know about the underpinning of mental illness, though he's not as convinced as Kirsch about the placebo effect and makes the point that the patients who turn up at his office are different from those recruited into clinical trials because drug companies, desperate to get their product to outperform a placebo, are picky about who they choose. You have to have "pure" depression, unblemished by alcohol use, anxiety problems, bipolar disorder, suicidal thoughts, mild or long-term depression – which, says Carlat, would exclude most of his patients. Yet, as Marcia Angell, author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It, says: "It's true... but they are the best we have." If there's one thing that's clear among the contradictions, it's that the brain remains mysterious. As Carlat says: "Undoubtedly, there are neurobiological and genetic causes for all mental disorders, but they are still beyond our understanding." All we really know is that depression exists and that sometimes the drugs seem to work – even if it's a placebo effect. Antidepressants: the guidelines * Never stop taking antidepressants without discussing it with your doctor, because abrupt cessation of SSRIs can cause withdrawal symptoms that can be both physical and mental. * If you do decide to stop, you'll need to reduce the dose gradually rather than stopping abruptly. * If you're happy with your antidepressant and you feel it works for you, then keep on taking it. Regular use is what works: if it ain't broke, don't fix it, says Professor Irving Kirsch. Further reading: Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America by Robert Whitaker