Table 1

STOP-PD II Inclusion and Exclusion criteria
    Inclusion criteria
1) Aged 18-85 years, inclusive
2) Diagnosis: DSM-IV non-bipolar major depression with psychotic features, established through both a clinical interview by a research psychiatrist and the subsequent administration of the SCID-IV by a research associate
3) Score of ≥3 on the delusion severity item of the SADS (‘delusion definitely present’), with or without hallucinations on the SADS hallucination item
4) Score of >2 on any of the three conviction items of the DAS (the participant is certain a belief is true and does not change the belief in response to reality testing by the interviewer);
5) 17-item Ham-D score of >21.
    Exclusion criteria
1) Current or lifetime DSM-IV criteria for: schizophrenia, schizoaffective disorder or other psychotic disorder, mental retardation, or meeting DSM-IV criteria for current brief psychotic disorder, body dysmorphic disorder, or obsessive-compulsive disorder
2) Current or lifetime DSM-IV criteria for bipolar affective disorder
3) History of DSM-IV defined substance abuse or dependence, including alcohol, within the last three months
4) DSM-IV defined Alzheimer’s dementia, vascular dementia, or dementia due to other medical conditions, or a history of clinically significant cognitive impairment prior to the index episode of depression, and/or a mean score of ≥4 on the 26-item IQCODE. The IQCODE will be used to screen for clinically significant cognitive decline that began prior to the index episode of PD (a cut score of 4 has been found to have a sensitivity of 84-93% and specificity of 88-94% in screening for dementia in general, psychiatric, and medical populations of older adults [30,31]
5) Type 1 diabetes mellitus (defined as insulin-dependent diabetes mellitus with onset < 35 years of age and/or diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis)
6) Acute or unstable medical illnesses (e.g., delirium; metastatic cancer; unstable diabetes, decompensated cardiac, hepatic, renal or pulmonary disease; stroke; or myocardial infarction) within the last three months; current abnormal serum free T4; current abnormally low serum vitamin B12 or folic acid level; medical conditions and/or medications for which psychotic or depressive symptoms can be a direct manifestation (e.g. Cushing’s disease, high-dose systemic corticosteroids, L-dopa); neurological disease associated with extrapyramidal signs and symptoms (e.g. Parkinson’s disease); epilepsy, if the person has had one or more grand mal seizures in the past 12 months
7) The need for treatment with any psychotropic medications other than sertraline, olanzapine, or lorazepam; or with an anticonvulsant medication with mood-stabilizing properties (carbamazepine, lamotrigine, valproic acid)
8) Current pregnancy or a plan to become pregnant during the duration of the study in woman of childbearing age; breast-feeding in woman with infants
9) A clearly documented history of being unable to tolerate sertraline and/or olanzapine, including having had an untoward previous reaction to sertraline such as significant bradycardia (heart rate of <50 bpm) or development of the syndrome of inappropriate antidiuretic hormone secretion with a serum sodium of 129 mmol/L or below
10) History of non-response of the index episode of PD to at least a 6-week trial of ≥150 mg/day sertraline combined with ≥ 15 mg/day olanzapine
11) Patients showing ongoing improvement in the index episode of PD with treatment, other than sertraline and olanzapine, initiated prior to the study
12) Sufficiently ill to require immediate ECT (e.g., imminent risk of suicide, refusing to eat or severe malnutrition, catatonic)

Flint et al.

Flint et al. BMC Psychiatry 2013 13:38   doi:10.1186/1471-244X-13-38

Open Data