NCT00838032 2009.
| Trial name or title | Pilot study to evaluate the efficacy and safety of quetiapine fumarate instant‐release (Seroquel IR) in controlling agitation and aggressive symptoms in the acute treatment of patients with schizophrenia |
| Methods | Allocation: randomised. Blindness: single. Duration: 14 days |
| Participants | Diagnosis: CCMD‐3 diagnosis of schizophrenia with agitation. N = not stated. Age: > 18 < 65. Sex: males and females. History: not stated. Exclusion: pregnancy or lactation, risk of suicide, self‐harm or harm to others, known intolerance or lack of response to quetiapine fumarate or haloperidol, use of ketonazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, saquinavir, phenytoin, carbamazepine, rifampin, St. John's Wort and glucocorticoids two weeks prior to the trial, depot anti‐psychotic within one dosing interval (for the depot) before randomisation, CCMD diagnosis of substance or alcohol dependence at enrolment (exception of caffeine or nicotine), use of opiates, amphetamine, cocaine, cannabis, barbiturates or hallucinogens within four weeks prior, medical conditions that would affect the absorption, distribution, metabolism, or excretion of study treatment, unstable or inadequately treated medical illnesses, involvement in the planning and conduct of the study, previous enrolment or randomisation in the present study, participation in another drug trial within four weeks prior to enrolment or in accordance with local requirements, a person with diabetes mellitus, an absolute neutrophil count of 1.5 x 109 per litre, 2 x higher than normal upper limit of ALT or AST, use of clozapine within 28 days prior to randomisation. Setting: psychiatric inpatient ward, China. |
| Interventions | 1. Haloperidol. 2. Quetiapine. |
| Outcomes | Not stated. |
| Starting date | August 2008. |
| Contact information | Bo Zhang, PhD 13808203275 zb_73@126.com |
| Notes | Protocol, full characteristics and outcome data not reported. Attempted to contact author to enquire whether there are any available data. |
ALT: alanine aminotransferase AST: aspartate transaminase CCMD: Chinese Classification of Mental Disorders