Cornelius 2016.
Methods | Randomized, double‐blind, placebo‐controlled trial | |
Participants | 14 depressed people with alcohol dependence (10 men and 4 women; mean age = 41.3 years) Inclusion criteria:
Exclusion criteria:
Participants with bipolar disorder: information not available |
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Interventions | Drugs:
Psychotherapy:
Scheduled duration of treatment: 12 weeks Site: University of Pittsburgh, Western Psychiatric Institute and Clinic, Pittsburgh, USA Setting: outpatients Route of administration: orally Starting dose:
Pattern of dose reduction: information not available |
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Outcomes | Depression:
Alcohol dependence:
Craving for alcohol:
Dropouts Adverse effects |
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Notes |
Baseline characteristics of participants Depression:
Alcohol dependence:
Other psychiatric comorbidity: participants with other mental disorders were excluded. Other substance use disorders: participants with substance use disorders were excluded. Other characteristics of study Other pharmacological treatment: participants did not receive other pharmacological treatments. Funding sources: study received grants from the National Institute on Alcohol Abuse and Alcoholism (R21 AA022123, R21 AA022863, R01 AA013370, R01 AA015173, K24 AA15320) and from the National Institute on Drug Abuse (R01 DA019142, P50 DA05605, K02 DA017822). Declarations of interest: information not available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about sequence generation process to permit judgement of low or high risk. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Medications were identical in appearance (identical‐looking opaque capsules). |
Blinding of outcome assessment (detection bias) objective | Low risk | Medications were identical in appearance (identical‐looking opaque capsules). |
Blinding of outcome assessment (detection bias) subjective | Unclear risk | No information on the blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat approach reported. |
Selective reporting (reporting bias) | Low risk | No dropouts |