Cocchi 1997.
Methods | Randomized comparative trial | |
Participants | 122 depressed people with alcohol dependence (95 men and 27 women; mean age: 42 years) Inclusion criteria:
Exclusion criteria: information not available Participants with bipolar disorder: information not available |
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Interventions | Drugs:
Psychotherapy: information not available Scheduled duration of treatment: 3‐4 weeks Site: Alcohol Unit, casa di Cura Villa Silvia per malattie nervose e mentali, Senigallia, Italy Setting: inpatients Route of administration: orally Starting dose: information not available Pattern of dose reduction: information not available |
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Outcomes | Depression
Alcohol dependence: data not available Dropouts: data not available Adverse effects: data not available |
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Notes |
Baseline characteristics of participants Depression:
Alcohol dependence: data not available Other psychiatric comorbidity: information not available Other substance use disorders: information not available Other characteristics of study Other pharmacological treatment: information not available Funding sources: information not available Declaration of interest: information not available Other information Data on response and remission were excluded because evaluated using a self‐administered scale. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random allocation stated. No further details provided. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No information on the design (double‐blind or open trial), on the preparation and appearance of medications, and on blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) objective | Low risk | No information on study design (double‐blind or open trial). |
Blinding of outcome assessment (detection bias) subjective | High risk | No information on study design (double‐blind or open trial). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Methods applied to account for missing data. Intention‐to‐treat approach not reported. No high number of dropouts or unbalanced between groups. |
Selective reporting (reporting bias) | Unclear risk | Information insufficient to permit judgement. |