Currently funded project provided data on 111 schizophrenic and schizoaffective patients assigned at random to haloperidol (HAL) treatment at fixed plasma levels ranging from 2 to 34 ng/ml. No relationship between plasma levels and clinical efficacy has emerged. This result suggests that the current clinical practice may be wrong; patients are apparently receiving higher doses of HAL than they need. This is an important problem, particularly because of the HAL side effects. The primary goal of this continuing project is to determine the clinical efficacy of very low plasma levels of HAL in schizophrenia. The subjects will be acutely exacerbating schizophrenics newly admitted to inpatient services. a total of 180 subjects will be treated with one of the two plasma level HAL ranges: """"""""low"""""""" (0.5-3.5 ng/ml), or """"""""high"""""""" (8.5-11.5 ng/ml). Lorazepam and benztropine will be available as concomitant medications if needed. The subjects will be maintained in their randomly assigned HAL range for 3 weeks. Those who fail to improve at the end of this period will be randomly assigned to either the same level or to the other HAL level range for another 3 weeks. The patient evaluations will include the BPRS, SAPS, SANS, and Simpson-Angus Scale. Blood assays for HAL will be used for dose adjustments. All evaluations and assays will be double-blind. The principal three hypothesis to be tested: 1. High and low levels of HAL will yield similar clinical improvement at the endpoint of the first three week period; 2. The subjects who fail to respond to the low level of HAL during the first 3 weeks will not appreciably benefit from the switch to the high level. 3. The two levels of HAL will have a similar speed of onset of clinical effect.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH041772-05
Application #
3380544
Study Section
Treatment Development and Assessment Research Review Committee (TDA)
Project Start
1987-02-01
Project End
1994-03-31
Budget Start
1991-04-01
Budget End
1992-03-31
Support Year
5
Fiscal Year
1991
Total Cost
Indirect Cost
Name
Nathan Kline Institute for Psychiatric Research
Department
Type
DUNS #
167204762
City
Orangeburg
State
NY
Country
United States
Zip Code
10962
Volavka, J; Cooper, T B; Czobor, P et al. (2000) High-dose treatment with haloperidol: the effect of dose reduction. J Clin Psychopharmacol 20:252-6
Czobor, P; Volavka, J (1996) Dimensions of the Brief Psychiatric Rating Scale: an examination of stability during haloperidol treatment. Compr Psychiatry 37:205-15
Czobor, P; Volavka, J (1996) Positive and negative symptoms: is their change related? Schizophr Bull 22:577-90
Volavka, J; Cooper, T B; Czobor, P et al. (1996) Effect of varying haloperidol plasma levels on negative symptoms in schizophrenia and schizoaffective disorder. Psychopharmacol Bull 32:75-9
Volavka, J; Cooper, T B; Laska, E M et al. (1996) Placebo washout in trials of antipsychotic drugs. Schizophr Bull 22:567-76
Volavka, J; Cooper, T B; Czobor, P et al. (1995) Plasma haloperidol levels and clinical effects in schizophrenia and schizoaffective disorder. Arch Gen Psychiatry 52:837-45
Convit, A; Volavka, J; Czobor, P et al. (1994) Effect of subtle neurological dysfunction on response to haloperidol treatment in schizophrenia. Am J Psychiatry 151:49-56
Krakowski, M I; Kunz, M; Czobor, P et al. (1993) Long-term high-dose neuroleptic treatment: who gets it and why? Hosp Community Psychiatry 44:640-4
Czobor, P; Volavka, J (1993) Quantitative electroencephalogram examination of effects of risperidone in schizophrenic patients. J Clin Psychopharmacol 13:332-42
Czobor, P; Volavka, J (1992) Level of haloperidol in plasma is related to electroencephalographic findings in patients who improve. Psychiatry Res 42:129-44

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