Wu 2015.
Methods | Randomised controlled trial |
Participants |
Insomnia diagnosis criteria: PSQI score ≥ 7 Number of participants randomised: n = 78 Number of participants: n = 71 Citalopram: n = 35 Doxepin: n = 36 Age range: 45‐64 years Gender of those randomised (M/F): Citalopram: 35.9%/64.1% Doxepin: 20.5%/79.5% Race/ethnicity: not mentioned, but presumably Chinese Country: China Setting: The Jinshan Hospital of Fudan University Included: aged 45‐64 years who had not received any psychotropic drugs for ≥ 2 weeks or hormonal agents and immunomodulators in the 6 months prior to initiation of study. Excluded: severe medical conditions (cancer, cardiovascular and cerebrovascular diseases, thyroid disorders), pregnancy and lactation and mental retardation disorders. Withdrawals: 3 participants in citalopram group and 2 participants in doxepin group did not complete the study due to adverse drug reactions Baseline imbalances: 15.4% more women in doxepin group at randomisation |
Interventions |
Intervention: citalopram 20 mg/day, taken after breakfast Comparison: doxepin 12.5 mg/day, taken 30 min before sleep at night |
Outcomes |
Primary outcomes PSQI HAMA Headache, aggravated insomnia, blood pressure increase, hyperexcitability, nausea and vomiting, dizziness, palpitations, frequent urination, somnolence and numbness |
Notes |
AE: adverse event; CPAP: continuous positive airway pressure; DSM: Diagnostic and Statistical Manual of Mental Disorders; F: female; HAMA: Hamilton Anxiety Rating Scale; hr: hour; IGR: Investigator Global Rating; ISI: Insomnia Severity Index; lb: pounds; LOCF: last observation carried forward; LPS: latency to persistent sleep; m: male; MDD: major depressive disorder; n: number; NAW: number of awakenings; Pg: page; PLMAI: periodic limb movements associated with arousal; SF‐36: 36‐item Short Form; PSG: polysomnography; PSQI: Pittsburgh Sleep Quality Index; SD: standard deviation; SL: sleep latency; sTST: subjective total sleep time; TST: total sleep time; VAS: visual analogue score; WASO: wake after sleep onset.