Effects of a six-week drug holiday on symptom status, relapse, and tardive dyskinesia in chronic schizophrenics.

We have conducted a 6-wk drug withdrawal study in a group of chronic schizophrenic outpatients who had been maintained on injectable fluphenazine decanoate for at least 2 yr prior to the study. After two baseline assessments, patients were randomly assigned to two groups. The first group (holiday) received a placebo injection from a nurse who was not involved in the assessment (N = 17). The second group continued on their regular medication (N = 14). The assessment was done in a double-blind fashion at 3 and 6 wk using the Schedule for Affective Disorders and Schizophrenia (SADS) and the Global Assessment Scale (GAS) inventories to assess symptom status. Tardive dyskinesia was measured using the Abnormal Involuntary Movement Scale (AIMS). Community adjustment was assessed by means of the self-rated Weissman Social Adjustment Scale. We found that there were no relapses of any kind in either group of patients using the instruments mentioned above. The prevalence of tardive dyskinesia as measured by the AIMS was low, with only one patient having severe tardive dyskinesia. There was no significant worsening of the tardive dyskinesia during the drug holiday. Our study concludes that a 6-wk drug holiday was safe in this group of chronic schizophrenic patients maintained on fluphenazine decanoate. In contrast to other studies, no cases of covert tardive dyskinesia were detected during the drug holiday.

RCT Entities:   Population Interventions Outcomes