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. 2021 Feb 16;2021(2):CD013281. doi: 10.1002/14651858.CD013281.pub2

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
  • Sex (N, % female, % male): female 33 (83%), male 7 (17%)

  • Age (N, %): <20 years 1 (2%), 30 to 50 years 36 (90%), >50 years 3 (7%)

  • Number of participants: 40


Imipramine
  • Sex (N, % female, % male): female 34 (85%), male 6 (15%)

  • Age (N, %): < 20 years 3 (7%), 20‐50 years 34 (85%), >50 years 3 (7%)

  • Number of participants: 40


Overall
  • Sex (N, % female, % male): female 67 (84%), male 13 (16%)

  • Age: not reported

  • Number of participants: 80


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
  • Class of drug: Antidepressant (SSRI)

  • Dose: 20‐25 mg

  • Frequency: per day

  • Duration: 8 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: pharmacological


Imipramine
  • Class of drug: Antidepressant (TCA)

  • Dose: 50‐100 mg

  • Frequency: per day

  • Duration: 8 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: pharmacological

Outcomes Fasting blood sugar
  • Outcome type: Continuous

  • Reporting: Fully reported

  • Unit of measure: mg/dl

  • Direction: Lower is better

  • Data value: Endpoint

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.