Salehi 2009.
Study characteristics | ||
Methods |
Study design: Randomized controlled trial Study grouping: Parallel group How were participants recruited: Randomly selected patients with major depressive disorder referred to the researcher's private clinic at Arak Medical Center and Shahid Hashemi Arak Neurology and Psychiatric Clinic in 2005. Type of RCT: Unclear |
|
Participants |
Baseline characteristics Fluoxetine
Imipramine
Overall
Inclusion criteria: Diagnosis of major depression (DSM‐IV‐TR), lack of diabetes of family history, no use of effective blood glucose medication, no history of heart, kidney and liver disease, age between 20 to 50 years old,no prohibition to use Flouxetin and Imipramine, not taking antidepressants or electroshock therapy in the last 3 months. Exclusion criteria: Drug sensitivity, patient discontinuation, patient's reluctance and unwillingness to continue treatment, hyperglycemia, non‐response, change of medication, and pregnancy. Pretreatment: No significant differences observed. Similar proportion of participants with acute versus chronic depression in both groups. Similar baseline glucose values. |
|
Interventions |
Intervention characteristics Fluoxetine
Imipramine
|
|
Outcomes |
Fasting blood sugar
|
|
Identification |
Sponsorship source: Not reported Country: Iran Setting: Arak Medical Center Comments: ‐ Authors name: Dr. Bahman Salehi Institution: Arak Medical University Email: basalehi@yahoo.com Address: Arak Medical University, Arak, Iran |
|
Notes | Translated from Persian. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: There is insufficient information regarding how randomization was achieved although abstract and methods say trial was randomized. |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: There is no mention of allocation concealment in the study |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: There is no mention of blinding of personnel or participants in the study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: There is mention of blinding of outcome assessment in the study but testing was done by a technician. Blinding is unlikely to influence the outcome of fasting blood sugar as an objective outcome. It therefore was not likely that a lack of blinding influenced the outcome measurement. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Judgement comment: No drop‐outs reported; discontinuation or reluctance to continue are reasons for exclusion. . Non‐response to medication is mentioned as a reason for exclusion, as is patient discontinuation. Inclusion/ exclusion criteria appear to have been applied retrospectively to remove 'unsuitable' participants from the study. |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: There is no reference to a protocol or trial registration. |
Other sources of bias | High risk | Judgement comment: ‐ The study does not clarify what the "specific dietary recommendations" were. |