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. 2015 Jan 16;2015(1):CD009831. doi: 10.1002/14651858.CD009831.pub2

Glazer 1990.

Methods Randomisation: “randomly assigned”.
Blinding: double‐blind.
Duration: at least 2 weeks.
Design: parallel.
Location: not indicated.
Setting: outpatients.
Participants Diagnosis: chronic or subchronic schizophrenia or schizoaffective disorder (research diagnostic criteria) and occurence of tardive dyskinesia.
N = 18.
Gender: 8M, 10F.
Age: mean 47 years.
History: duration stable: not indicated, duration of illness: mean 2.58 years, number of previous hospitalisations: mean 4.6, age at onset: not indicated, severity of illness: not indicated, baseline antipsychotic dose: not indicated.
Interventions 1. Haloperidol: flexible dose, dose range: 19.3 mg to 34.3 mg/day, mean dose: not indicated. N = 9.
2. Molindone: flexible dose, dose range: 75 mg to 145 mg/day, mean dose: not indicated. N = 9.
 
“Medication dosing was determined by the occurrence of side effects or psychiatric symptoms.”
Outcomes Examined:
Leaving the study early due to any reason.
Leaving the study early due to inefficacy of treatment.
Leaving the study early due to adverse effects.
Unable to use:
Global state general: Clinical Global Impression (CGI) (no raw data available).
Mental state general: Brief Psychiatric Rating Scale (BPRS) (no raw data available).
Adverse effects: Abnormal Involuntary Movement Scale (AIMS) (no information available to calculate the values for both study group).
Adverse effects: Treatment Emergent Symptoms Scale (TESS) (no raw data available).
Adverse effects: Webster Parkinsonism Rating Scale (no raw data available).
Notes Inclusion criteria: participants had to 1. “met research diagnostic criteria for chronic or subchronic schizophrenia or schizoaffective disorder”; 2. “meet diagnostic criteria for TD [tardive dyskinesia]” and 3. “have at least 12 months exposure to neuroleptic medication” other than molindone or haloperidol.
31 subjects agreed to participate in this study, but only 18 participants fulfilled subsequently the criterion for withdrawal‐exacerbated TD during the drug‐free period and were randomised to the study medications.
“Neuroleptic medications were tapered over a 7‐10 day period and then withdrawn, with single‐blind substitution of placebo for 7‐14 days.” The participants who met the criterion for withdrawal‐exacerbated TD (18 0f 31 participants) during the drug‐free period “were then admitted to a masking phase in which they were randomly assigned to receive either molindone or haloperidol.”
“If the patient experienced no side effects or psychiatric  symptoms, the dose was raised during the first week from 100% to the second week when about 200% dose equivalency of the patient’s prestudy neuroleptic medication was given .
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “Randomly assigned”. No further details.
Allocation concealment (selection bias) Unclear risk No further details.
Blinding (performance bias and detection bias) 
 (performance bias) Low risk “Double‐blind”. “Medication was supplied in identical‐appearing capsules.”
Blinding (performance bias and detection bias) 
 (detection bias) Unclear risk “Double‐blind”. No further details.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Of the 18 randomised participants, who fulfilled the criterion for withdrawal‐exacerbated TD nobody left the trial early.
Selective reporting (reporting bias) High risk The outcome data were not fully addressed (no raw data for the CGI, BPRS, TESS, and the Webster Parkinsonism Rating Scale). Adverse effects reporting was incomplete.
Other bias High risk Baseline imbalance between the two study groups in terms of post hospitalisation duration. The trial was not characterised through a definite endpoint.