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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āNegative 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, nothingās worked,ā he said.
On the contrary, itās distressing. Not being able to effectively navigate society is distressing, maybe not hallucination level distress, but still, itās real, too.
"ā¦ the company plans to start a 501-patient phase 3 trial before the end of this year. āWe had an āend of phase 2 meetingā with them,ā he said. Multiple countries will participate in the upcoming study, including the United States.
I donāt know how many phases it has to go through, but phase 3 should be started before December.
Thereās 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.
Iām just hoping the placebo effect wonāt blow their trial. At least they are doing genetic testing, if they had people in the trial that couldnāt metabolize the drug, that would throw the results too. Looks like theyāre testing different doses in poor and extensive metabolizers. Thatās cool.
What kind of negative symptoms does it treat? I love how they never tell you. I need something to work on my emotional flatness. I would do anything to feel positive happy emotions again.
Research is so politicized these days. Big pharma, medical establishment and politicians donāt 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, donāt pose a risk to others and can work those small āinsignificantā jobs, I believe itās 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.