Treating negative symptoms in schizophrenia has always been a challenge for clinicians. Currently there are no drugs approved by the US Food and Administration (FDA) for this specific indication. But recent research findings may offer new hope.
Although antipsychotic medications help treat main/primary positive symptoms of schizophrenia, such as hallucinations and delusions, they have not been effective in treating primary negative symptoms, such as apathy, lack of emotion, and poor social functioning.
However, recently published results from a phase 2b trial of 244 patients showed that those who received either 32 mg/day or 64 mg/day of the investigational antipsychotic MIN-101 (Minerva Neurosciences) had lower scores at 12 weeks on the Positive and Negative Syndrome Scale (PANSS) than those receiving placebo.
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“Negative symptoms are a prevalent dimension of schizophrenia, and, while not distressing, they are certainly disabling in terms of limiting functioning. And while there have been a number of shots on goal in terms of treating these symptoms, nothing’s worked,” he said.
On the contrary, it’s distressing. Not being able to effectively navigate society is distressing, maybe not hallucination level distress, but still, it’s real, too.
"… the company plans to start a 501-patient phase 3 trial before the end of this year. “We had an ‘end of phase 2 meeting’ with them,” he said. Multiple countries will participate in the upcoming study, including the United States.
I don’t know how many phases it has to go through, but phase 3 should be started before December.
There’s a phase 3a and a 3b. The third phase takes an average of 3 years, but could take less. Then the FDA takes usually 1 to 2 years to review and approve, but this could be faster too.
I’m just hoping the placebo effect won’t blow their trial. At least they are doing genetic testing, if they had people in the trial that couldn’t metabolize the drug, that would throw the results too. Looks like they’re testing different doses in poor and extensive metabolizers. That’s cool.
Research is so politicized these days. Big pharma, medical establishment and politicians don’t always have our best interest at hand. Who knows how all 3 of them feel about a cure for our illness and esp. negative and cognitive symptoms.
As long as we are not delusional, don’t pose a risk to others and can work those small “insignificant” jobs, I believe it’s ok for them.
Only some well intentioned researchers who have seen how distressful our disease can be, who have experienced it first-hand in their families are on our side.