Depression in adults: treatment and management Appendix J11: study characteristics for evidence from previous versions of the guideline (St John’s wort, seasonal affective disorder and relapse prevention) Depression in adults: Appendix J11 1 Contents Treatment of a new depressive episode ................................................................................................. 3 St John’s wort - studies in 2004 guideline ........................................................................................... 3 Seasonal affective disorder ................................................................................................................. 8 Light therapy - new studies in the guideline update ...................................................................... 8 Non-light therapy interventions for depression with a seasonal pattern/SAD ............................ 31 Relapse prevention ............................................................................................................................... 35 2004 Guideline .............................................................................................................................. 35 2009 Guideline .............................................................................................................................. 40 Seasonal affective disorder ............................................................................................................... 49 Non-light therapy interventions for depression with a seasonal pattern/SAD - relapse prevention ..................................................................................................................................... 49 Depression in adults: Appendix J11 2 1 Treatment of a new depressive episode 2 St John’s wort - studies in 2004 guideline 3 Characteristics of included studies 4 Study Methods Participants Interventions Outcomes Notes A C Behnke2002 Y Allocation: Random (no Inpatients and outpatients. Age: 18-73. St John's wort (300mg = 2 x 150mg HRSD-17 mean change scores B M C A details) Duration: 6 N=70. Diagnosis: ICD-10 Hypericum perforatum: 0.450- Non-responders (patients not achieving weeks Analysis: 0.495mg total hypericin per tablet) Depression (F32), HRSD≥16 and completer ≥50% decrease in HRSD) Fluoxetine (40mg) ≤24. Mean baseline HRSD: SJW - 20 +- Leaving the study early 3.2, Fluoxetine - 20.7 +-2.9. Patients reporting adverse effects Bergmann93 Y Allocation: Random (no Outpatients. Age: 25-83. N= 80. St John's wort HRSD-17 mean endpoint scores B O I A details) Duration: 6 Diagnosis: ICD-10 mild- moderate Amitriptyline Leaving the study early weeks Analysis: ITT depressive episode. Mean baseline HRSD: SJW - Leaving the study early due to side effects 15.82 +-0.70, amitriptyline - 15.26 Patients reporting adverse effects +-0.74 Non-responders (patients not achieving ≥50% decrease in HRSD) Brenner00 Y O Allocation: Random (no Outpatients. Age: 18-65. N=30. Diagnosis: St John's wort (600mg -> 900mg LI HRSD-17 mean endpoint scores Dose of sertraline was B I A/L details) Duration: 7 DSM-IV major depression recurrent (21 160) below the therapeutic Non-responders (patients not achieving weeks Analysis: ITT patients) or single episode (9 patients) level. Sertraline (50mg -> 75mg) and HRSD≥17, baseline HRSD=21.5+-3.1 ≥50% decrease in HRSD) Leaving the study early Leaving the study early due to side effects Davidson02 Allocation: Random (no Outpatients. Age: 18+. N=340. Diagnosis: St John's wort (900 up to 1500mg HRSD-17 mean change scores Dose of sertraline was B YOI A/L P details) Duration: 8 DSM-IV major depressive disorder and LI 160: standardised to 0.12-0.28% below the therapeutic Non-responders (patients not achieving ≥50 decrease in HRSD weeks Analysis: ITT - HRSD- 17≥20, baseline = 22.5-23.1 hypericin) level and 12≥HRSD≥9) LOCF Sertraline (50mg up to 100mg) Non-remitters (patients not achieving HRSD Placebo ≤ 8) Leaving the study early Leaving the study early due to side effects Depression in adults: Appendix J11 3 Study Methods Participants Interventions Outcomes Notes A C Hansgen1996 Allocation: Random (no Outpatients and primary care patients. 1. St John's wort (900mg = 1. HRSD mean endpoint scores B Y M C P details) Duration: 4 N=108. Age: 18-70. Diagnosis: DSM-III-R 3x300mg LI 160) Non-responders (patients not achieving weeks Analysis: major depression, HRSD≥16. 2. Placebo completer ≥50% decrease in HRSD) Leaving the study early Patients reporting adverse effects Harrer94 Y O C Allocation: Random (no Outpatients. N=102. Age: 24-65. St John's wort (900mg = 3x 300mg HRSD-17 mean endpoint scores Dose of maprotiline was B A/L details) Duration: 4 Diagnosis: ICD-10 Moderate depressive LI 160) below the therapeutic Non-responders (patients not achieving weeks Analysis: episode, HRSD- 17≥16. Mean baseline level Maprotiline (75mg) Completers HRSD: SJW - 20.5, maprotiline - 21.5 ≥50% decrease in HRSD or HRSD≤10) Leaving the study early due to side effects Leaving the study early Patients reporting adverse effects Harrer99 E O I Allocation: Random (no Outpatients. N=161. Age: 60-80. St John's wort (800mg = 4 x 200mg HRSD-17 mean endpoint scores ITT sample=149. B A details) Duration: 6 Diagnosis: ICD-10 mild- moderate LoHyp-57: drug extract ratio 5-7:1) Non-responders (patients not achieving HRSD≤10 or >=50% weeks Analysis: ITT - depressive episode, baseline HRSD 16.6- Fluoxetine (20mg) decrease in HRSD) LOCF 17.18 Leaving the study early Leaving the study early due to side effects Patients reporting adverse effects Kalb2001 Y O I Allocation: Random (no Outpatients. N=72. Age: 18-65. Diagnosis: St John's wort (900mg = 3 x 300mg HRSD-17 mean change scores B P details) Duration: 6 DSM-IV mild- moderate major depression WS5572: drug extract ratio 2.5-5:1, Non-responders (patients not achieving weeks Analysis: ITT and HRSD≥16. Mean baseline HRSD: 5% hyperforin) SJW - 19.7 +-3.4, range 16-34; ≥50% decrease in HRSD) Placebo placebo - 20.1 +-2.6, range 16-26. Leaving the study early Leaving the study early due to side effects Patients reporting adverse effects Laakmann98 Y Allocation: Random (no Outpatients. N=147. Age: 18-65. St John's wort (900mg = 3 x 300mg HRSD-17 mean change score Data extracted for B O I P details) Duration: 6 Diagnosis: DSM-IV mild or moderate WS5572: 5% hyperforin) higher dose SJW (1) Non-responders (patients not achieving weeks Analysis: LOCF depression and HRSD-17≥17. Mean and placebo (3). St John's wort (900mg = 3 x 300mg baseline HRSD: SJW - 20.9 +-3.1, ≥50% decrease in HRSD) WS5573: 0.5% hyperforin) placebo Leaving the study early Placebo - 21.2 +-3.3 Leaving the study early due to side effects Patients reporting adverse effects Depression in adults: Appendix J11 4 Study Methods Participants Interventions Outcomes Notes A C Lecrubier02 Y Allocation: Random (no Outpatients. Age: 18-66. N=375. 1 St John's wort (900mg = 3 x HRSD-17 mean change scores B O I P details) Duration: 6 Diagnosis: DSM-IV mild - moderate 300mg WS5570: 0.12- Non-responders (patients not achieving weeks Analysis: ITT - depression and 25=>HRSD≥18, baseline 0.28% hypericin) LOCF = 21.9 ≥50% decrease in HRSD) 2. Placebo +-1.7, range: 18-27 Leaving the study early Leaving the study early due to side effects Non-remitters (patients not achieving HRSD≤6) Patients reporting adverse effects Philipp99 Y O I Allocation: Random (no Primary care patients(?). N=263. Age: 18- 1. St John's wort (1050mg = 3 x 1. HRSD-17 mean change scores A P details) Duration: 8 65, mean=47. Diagnosis: ICD-10 350mg STEI 300: 0.2- 0.3% weeks Analysis: ITT - moderate depressive episode and HRSD- hypericin, 2-3% hyperforin) 2. Non-responders (patients not achieving ≥50% decrease in LOCF 17 ≥18, baseline=22.6 +-4.1 HRSD) 2. Imipramine (50mg -> 100mg) 3. Leaving the study early 3. Placebo 4. Leaving the study early due to side effects Philipp99 Y O I Allocation: Random (no Primary care patients(?). N=263. Age: 18- 1. St John's wort (1050mg = 3 x 5. HRSD-17 mean change scores A P details) Duration: 8 65, mean=47. Diagnosis: ICD-10 350mg STEI 300: 0.2- 0.3% 4. Patients reporting adverse effects weeks Analysis: ITT - moderate depressive episode and HRSD- hypericin, 2-3% hyperforin) 6. Non-responders (patients not achieving ≥50% decrease in LOCF 17 ≥18, baseline=22.6 +-4.1 HRSD) 5. Imipramine (50mg -> 100mg) 7. Leaving the study early 6. Placebo 8. Leaving the study early due to side effects Schrader00 Y Allocation: Random (no Outpatients. N=240. Age: 18+, mean = St John's wort (500mg = 2 x 250mg HRSD-21 mean change scores B O I A details) Duration: 6 56.5. N=240. Diagnosis: mild - moderate ZE117 (drug extract ratio 4-7:1) Patients reporting adverse effects 7. Non-responders (patients not achieving HRSD≤10 or ≥50% weeks Analysis: ITT - depressive episode, 24≥HRSD≥16, mean Fluoxetine (20mg) decrease in HRSD) LOCF HRSD = 19.5-19.65 Leaving the study early due to side effects Patients reporting adverse effects Schrader98 Y Allocation: Random (no N=162. Age: 18+. Diagnosis: ICD-10 mild St John's wort (500mg = 2 x 200mg HRSD-21 mean change scores B details) Duration: 6 or moderate depressive episode and 16=< ZE117: 0.5mg hypericin) ? I P Non-responders (patients not achieving weeks Analysis: ITT HRSD≤24. Mean baseline HRSD: SJW - Placebo 20.13, placebo - 18.76 ≥50% decrease in HRSD or HRSD≤10) Patients reporting adverse effects Depression in adults: Appendix J11 5 Study Methods Participants Interventions Outcomes Notes A C Shelton 2001 Y Allocation: Random (no Outpatients. N=200. Age: 18+. Diagnosis: