A two-phase, double-blind randomized study of three haloperidol plasma levels for acute psychosis with reassignment of initial non-responders.
To clarify the plasma level/therapeutic response relationship of haloperidol (HPDL) we used a prospective double-blind design in 95 acutely psychotic patients. After drug washout, patients were randomly assigned to a low, middle or high plasma level range for 2 weeks (phase A), and then 50% of the initial non-responders were randomly reassigned into the putative therapeutic range for an additional 2 weeks (phase B). There were no significant differences in clinical outcome between the three plasma level ranges in phase A. However, in phase B initial non-responders displayed greater improvement in the middle range than in the low or the high ranges. No further benefit was observed when plasma levels were raised to or maintained in the high range.
Janicak
P G
PG
Department of Psychiatry, University of Illinois at Chicago 60612, USA.
Javaid
J I
JI
Sharma
R P
RP
Leach
A
A
Dowd
S
S
Davis
J M
JM
D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000097:blood* / Q000188:drug therapy / Q000523:psychology; D012559:Schizophrenia / Q000097:blood* / Q000188:drug therapy; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D006220:Haloperidol