| Damania and Masani[4] |
8 days-4months |
N = 19 |
TRZ |
30-300 |
|
|
| Bhaskaran, 1963[6] |
6 |
N = 4 ; Open label |
TPZ |
60 |
|
|
| Jetley[8] |
6 |
N = 6 Open label |
HPL |
1.5-4.5 |
|
|
| Fernandeset al.[74] |
8 |
N = 25; CGI, BPRS, UKU, open study |
Zuclopenthixol |
Zuclopenthixol acuphase-50-150 Zuclopenthixol decanoate 200-600 |
Zuclopenthixol Acetate (acuphase) -category of severely ill reduced from 55% to 20.8% at 72 hours CGI very much improved and much improved - 27% at 24 hours and 34% at 72 hours Zuclopenthixol decanoate (depot)-CGI “very much Improved” 10% of the cases at the baseline, in 24% at 4 weeks and in 35% at 8 weeks. BPRS scores also showed significant reduction from a mean total score of 58 at the baseline to 39 at 4 weeks and 36 at 8 weeks |
Neurological S/E (tremors, rigidity, hypokinesia, dystonia, akathesia, hyperkinesia), depression, asthenia, increased salivation, sedation, hypotension, headache
|
| Khanna et al.[75] |
3 |
N = 291 DSM-IV, DBRPCT, YMRS, CGI, GAS, MADRS, PANSS, ESRS/Multicentric |
Risp vs. PBO |
1-6 |
Significantly higher reduction in YMRS score at 1st, 2nd and 3rd week in Risp group compared to PBO >50% reduction in YMRS score was seen in 73% patients in Risp group compared to 36% in PBO group Significant improvement in Risp group in CGI, GAS scores, PANSS total, MADRS Patients with mania had significantly greater improvement in YMRS score There was significant improvement in Risp group irrespective of age, gender and baseline YMRS score |
35% of subjects in Risp group experienced EPS (compared to 6% in the placebo group) Other side effect which was reported by more than 10% of subjects was insomnia; however, there was no difference between the 2 groups on the incidence of the same |
| Smulevich et al.[76] |
12 |
N = 438 DSM IV, DBRPCT YMRS, CGI, UKU |
HPL Vs. Risp Vs. PBO |
Risp 2-6 HPL 4-12 |
Significantly greater improvements in mean YMRS scores were seen with risperidone than with placebo at week 1 and at each subsequent assessment during the first three weeks. Differences between risperidone and haloperidol were not significant At the three weeks, more patients were treatment responders (>50% reduction in YMRS total scores) among those treated with risperidone (48%) or haloperidol (47%) than placebo (33%). The difference between risperidone and placebo was significant (P < 0.01) At 12 weeks, a > 50% reduction in YMRS total score was maintained in 98% (53/54) and 100% (37/37) of patients who responded at 3 weeks and continued on double blind therapy with risperidone and haloperidol, respectively. An additional 83% (30/36) and 89% (24/27) of subjects who did not reach a reduction of .50% in the YMRS total score on risperidone or haloperidol, respectively, at 3 weeks but continued on double-blind therapy were responders at 12 weeks |
Severity of most adverse events was mild or moderate Adverse events reported in $ 10% of patients during 12 weeks of doubleblind treatment were extrapyramidal disorder (24%), somnolence (10%), and hyperkinesia (10%) in the risperidone group and extrapyramidal disorder (43%), hyperkinesia (19%), tremor (13%), and hypertonia (10%) in the haloperidol group Mild or moderate depression was reported in seven (5%) risperidone patients and eight (6%) haloperidol patients |
