Strous 2007.
| Methods | Allocation: randomised.
Blindness: double.
Duration: 12 weeks. Funded by NARSAD Young Investigator Award. |
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| Participants | Diagnosis: schizophrenia. DSM IV, SCID.
N = 40.
Age: average 34 years (SD ˜ 10), range 18 to 58 years.
Sex: 27 M 13 F.
Setting: inpatient.
History: duration of illness 'chronic', longer than 2 years.
Excluded: people with any significant medical (including prostate illness) or neurological illness, pregnant women, people who had been administered mood stabilisers or any steroid or hormonal supplement (e.g. oestrogen). Country: Israel. |
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| Interventions | 1. DHEA: dose 50 mg/day for first 2 weeks, 100 mg/day for following 2 weeks, finally 150 mg/day for last 8 weeks (each administered in divided morning and evening doses). N = 20. 2. Placebo: N = 20. Other concurrent treatments: participants required to have been maintained on a stable dose of olanzapine for at least 1 month before study commencement. Participants were required to continue taking this dose of olanzapine throughout the duration of the study. Aside from olanzapine, concurrent medications allowed included medications that were clinically required before study recruitment to maintain and stabilise clinical status (e.g. benzodiazepines). Clinicians were requested to not change these ancillary medications over the course of the study. All participants entered a 1‐week, single‐blind, placebo lead‐in phase of the study. |
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| Outcomes | Mental state: total psychotic symptoms (PANSS), positive psychotic symptoms (PANSS), negative psychotic symptoms (PANSS), depression (CDSS). Global state: leaving the study early. Adverse events: extrapyramidal symptoms (parkinsonism) (SAS), body weight Unable to use cognitive functioning: 'Mindstreams' cognitive test battery (Go‐NoGo Response Inhibition Test, Stroop Interference Test, Staged Information Processing Speed tests); test of verbal and non‐verbal memory. Data not provided. Study authors reported no significant differences in cognitive performance between intervention and control groups. Adverse events: extrapyramidal symptoms (tardive dyskinesia, akathisia) (BARS/AIMS). Only data for intervention groups reported (Table 4). No analyses could be undertaken. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients then were randomised (by means of random number generation)..." (pg 97). |
| Allocation concealment (selection bias) | Low risk | Quote (from correspondence): "Randomisation numbers provided by statistician to research assistant assigning study medication and maintained under lock and key in concealed fashion" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Participant/providers: Yes. Quote: "...to receive either DHEA or placebo, each for 12 weeks in a double‐blind manner" (pg 97). Outcome assessors blinded (source: correspondence). |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind" ‐ probably undertaken. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded (source: correspondence). |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
| Selective reporting (reporting bias) | Low risk | All outcome measures reported. |
| Other bias | High risk | No data given on numbers of individuals screened for study inclusion. Tendency towards baseline imbalance in SANS scores (P value = 0.051). |
AIMS ‐ Abnormal Involuntary Movement Scale BARS ‐ Barnes Akathisia Rating Scale BDI ‐ Beck Depression Inventory
BPRS ‐ Brief Psychaitric Rating Scale BPRS PSS ‐ BPRS Positive Symptom Subscale CANTAB ‐ Cambridge Neuropsychological Test Automated Battery CDSS ‐ Calgary Depression Scale for Schizophrenia CGI‐S ‐ Clinical Global Impressions Scale CPZ ‐ Chlorpromazine CVLT ‐ California Verbal Learning Test DHEA ‐ Dehydroepiandrosterone DSM ‐ Diagnostic and Statistical Manual of Mental Disorders ESRS ‐ Extrapyramidal Symptom Rating Scale F ‐ Female
GSK ‐ GlaxoSmithKline HAMA Hamilton Scale for Anxiety HAMD ‐ Hamilton Scale for Depression HDRS‐17 ‐ Hamilton Depression Rating Scale ‐ 17 item LOCF ‐ Last observation carried forward M ‐ Male MADRS ‐ Montgomery‐Asberg Depression Rating Scale
NARSAD ‐ National Alliance for Research on Schizophrenia and Depression
NIH ‐ National Institutes of Health
NIMH ‐ National Institute of Mental Health OAS ‐ Overt Aggression Scale PANSS ‐ Positive and Negative Syndrome Scale for Schizophrenia
PMD ‐ Psychotic major depression QOL ‐ Quality of life SANS ‐ Scale for the Assessment of Negative Symptoms SAS ‐ Simpson‐Angus Extrapyramidal Symptom Scale SHRS ‐ St Hans Rating Scale UKU ‐ Udvalg for Kliniske Undersøgelser side effects rating scale
USPHS ‐ United States Public Health Service YMRS ‐ Young Mania Rating Scale