scholarly journals Cariprazine in Therapy of Delusions with a Therapeutic Resistance due to Traumatic Brain Injury Randomized, Double-Blind Placebo-Controlled Study

2021 ◽  
Vol 5 (2) ◽  
pp. 01-04
Author(s):  
NA Aliyev ◽  
ZN Aliyev

Objective: We studied cariprazine in therapy of delusions with a therapeutic resistance due to traumatic brain injury randomized, double-blind placebo-controlled study manner. Methods: to traumatic brain injury hundred patients (100 all men) whom we studied were under observation in Mental Health Center of the Ministry of Health of the Republic of Azerbaijan from January 2020 to June 2021. The method of randomization was given by lottery. Each patient was randomized to receive either in agreement of the instruction cariprazine (50 patients) over 5 day in dose 6 mg one times per os in morning after meet for 6 weeks or matched placebo (50 patients) in a double-blind manner. A structured clinical interview, for DSM-5Axis I Disorder, Patient Edition, was used to diagnose according to DSM-5 major or mild neurocognitive disorder due to traumatic brain injury. Result: All patients (50) treated with cariprazine treated participants responded by 6 weeks, versus two of the 50 placebo-treated participants (p<0.001). The most common and problematic side effect in the cariprazine group was not. Conclusion: The authors believe this to be the first double-blind placebo-controlled randomization study to test the efficacy of a cariprazine in the management of in therapy of delusions with a therapeutic resistance due to traumatic brain injury randomized, double-blind placebo-controlled study manner. They need to be replicated in a larger study group.

2021 ◽  
pp. 085-087
Author(s):  
Aliyev NA ◽  
Aliyev ZN

Objective: We studied cariprazine in therapy of visual hallucinations with a therapeutic resistance due to traumatic brain injury randomized, double-blind placebo-controlled study manner. Methods: To traumatic brain injury hundred patients (100 all men) whom we studied were under observation in Mental Health Center of the Ministry of Health of the Republic of Azerbaijan from January 2020 to June 2021. The method of randomization was given by lottery []. Each patient was randomized to receive either in agreement of the instruction cariprazine (50 patients) over 5 day in dose 6 mg one times per os in morning after meet for 12 weeks or matched placebo (50 patients) in a double-blind manner. A structured clinical interview, for DSM-5Axis I Disorder, Patient Edition, was used to diagnose according to DSM-5 major or mild neurocognitive disorder due to traumatic brain injury. Results: All patients (50) treated with cariprazine treated participants responded by 12 weeks, versus two of the 50 placebo-treated participants (p<0.001). The most common and problematic side effect in the cariprazine group was not. Conclusions: The authors believe this to be the first double-blind placebo-controlled randomization study to test the efficacy of a cariprazine in the management of in therapy of visual hallucinations with a therapeutic resistance due to traumatic brain injury randomized, double-blind placebo-controlled study manner. They need to be replicated in a larger study group.


1998 ◽  
Vol 16 (4) ◽  
pp. 1574-1581 ◽  
Author(s):  
A N Serafini ◽  
S J Houston ◽  
I Resche ◽  
D P Quick ◽  
F M Grund ◽  
...  

PURPOSE To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study. PATIENTS AND METHODS Patients with painful bone metastases secondary to a variety of primary malignancies were randomized to receive 153Sm-EDTMP 0.5 or 1.0 mCi/kg, or placebo. Treatment was unblinded for patients who did not respond by week 4, with those who had received placebo eligible to receive 1.0 mCi/kg of active drug in an open-label manner. Patient and physician evaluations were used to assess pain relief, as was concurrent change in opioid analgesia. RESULTS One hundred eighteen patients were enrolled onto the study. Patients who received 1.0 mCi/kg of active drug had significant reductions in pain during each of the first 4 weeks in both patient-rated and physician-rated evaluations. Pain relief was observed in 62% to 72% of those who received the 1.O-mCi/kg dose during the first 4 weeks, with marked or complete relief noted in 31% by week 4. Persistence of pain relief was seen through week 16 in 43% of patients who received 1.0 mCi/kg, of active drug. A significant correlation (P = .01) was observed between reductions in opioid analgesic use and pain scores only for those patients who received 1.0 mCi/kg 153Sm-EDTMP. Bone marrow suppression was mild, reversible, and not associated with grade 4 toxicity. CONCLUSION A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.


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