An urgent need exists for new treatments of schizophrenia that are effective against a broad range of symptoms and free of limiting safety issues. ITI-007 is a new molecular entity with a pharmacological profile that combines dose-related monoamine modulation with phosphorylation of intracellular signaling proteins.
Methods
A phase II randomized, double-blind, placebo- and active-controlled trial was conducted at 8 sites in the US and randomized 335 acutely psychotic adults with schizophrenia. ITI-007 (60 mg, 120 mg), placebo, or risperidone, included for assay sensitivity, was evaluated as monotherapy for 4 weeks. The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS) total score, with secondary analyses conducted on symptom subscales.
Results
ITI-007 60 mg (P=0.017, effect size=0.4) and risperidone (P=0.013, effect size=0.4) demonstrated antipsychotic efficacy superiority over placebo on the primary endpoint. The results of secondary analyses reflected improvements in negative and depressive symptoms by ITI-007 60 mg. ITI-007 120 mg did not separate from placebo. However, both doses of ITI-007 were well tolerated in this patient population as evidenced by low discontinuation and adverse event rates, and were associated with a benign metabolic profile as evidenced by significantly lower levels of prolactin, fasting glucose, total cholesterol and triglycerides than risperidone.
Conclusion
This mechanistically novel investigational drug ITI-007 was effective for the treatment of schizophrenia and comparable to placebo on safety measures in this trial. Secondary analyses indicated that ITI-007 improved negative and depression symptoms and might have expanded therapeutic efficacy in comparison to current antipsychotic drugs. (ClinicalTrials.gov, NCT01499563
So we have ITI-007, Cariprazine, and CBD medications coming out. Looks good. I hope one of them comes out by 2016. In the meantime, I plan on asking me doctor about Geodon or Latuda.
Not only was the med better than placebo, but it was better than risperidone (@60mg). The higher dose (120mg) was the one that did not have good results. It was just as good at treating positive symptoms as risperidone, and superior in treating negative symptoms at 60mg’s, with a very low side effect profile, the only clinically significant side effect being sedation at the 120mg dosage, which you wouldn’t want to take anyway since the 60mg dosage had better results over all.
EDIT: OK sorry guys, they changed the information on the link from the phase 2 trial results to phase 3 information. In phase 3 trials they are using 40mg and 60mg doses instead of 120mg.
Every medication has a therapeutic range - too low and its not helpful, too high and its bad for you. So the fact that the 120 mg dose didn’t help is not big deal and no big surprise.
It could end up being a good drug, Just something sounds fishy to me, Iv never known a med at a higher dose not even being more effective then placebo when a lower does is, Im not going to get my hopes up about it. Btw im on risperidone too so i feel your pain.