Second‐generation antidepressants for seasonal affective disorder

Kylie Thaler; Marlene Delivuk; Andrea Chapman; Bradley N Gaynes; Angela Kaminski; Gerald Gartlehner

doi:10.1002/14651858.CD008591.pub2

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Figure 1

Study flow diagram for efficacy.

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Figure 2

Study flow diagram for adverse effects.

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 4

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 5

Forest plot of comparison: Fluoxetine versus Light Therapy, outcome: 1.1 Response (> 50% improvement on 24‐item HAM‐D SIGH‐SAD).

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Figure 6

Forest plot of comparison: Fluoxetine versus Light Therapy, outcome: 1.2 Remission (response plus end score eight or less).

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Analysis 1.1

Comparison 1 Fluoxetine versus Placebo, Outcome 1 Response (> 50% improvement on 29‐item HAM‐D SIGH‐SAD).

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Analysis 1.2

Comparison 1 Fluoxetine versus Placebo, Outcome 2 Harm: Overall adverse effects.

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Analysis 2.1

Comparison 2 Fluoxetine versus Light Therapy, Outcome 1 Response (> 50% improvement on 24‐item HAM‐D SIGH‐SAD).

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Analysis 2.2

Comparison 2 Fluoxetine versus Light Therapy, Outcome 2 Remission (response plus end score eight or less).

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Analysis 2.3

Comparison 2 Fluoxetine versus Light Therapy, Outcome 3 Harm: At least one treatment‐emergent adverse effect.

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Analysis 2.4

Comparison 2 Fluoxetine versus Light Therapy, Outcome 4 Harm: Agitation.

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Analysis 2.5

Comparison 2 Fluoxetine versus Light Therapy, Outcome 5 Harm: Sleep disturbance.

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Analysis 2.6

Comparison 2 Fluoxetine versus Light Therapy, Outcome 6 Harm: Palpitations.

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Fluoxetine compared with placebo for seasonal affective disorder
Patient or population: Adults with seasonal affective disorder Settings: Outpatients Intervention: Fluoxetine Comparison: Placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	placebo	fluoxetine
Response (> 50% improvement on 29‐item HAM‐D SIGH‐SAD) Five weeks	Medium risk population		RR 1.62 (0.92 to 2.83)	68 (1)	⊕⊝⊝⊝ very low¹
	34 per 100	56 per 100 (32 to 97)
Remission	NR	NR	NA	NA	NA
Quality of life	NR	NR	NA	NA	NA
Overall adverse effects Five weeks	Medium risk population		RR 1.07 (0.95 to 1.21)	68 (1)	⊕⊝⊝⊝ very low¹
	91 per 100	97 per 100 (86 to 110)
The basis for the assumed risk* (e.g. the median control group risk across studies) is the rate in the placebo group. The corresponding risk (and its 95% CI) is based on the assumed risk in the fluoxetine group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; HAM‐D SIGH‐SAD: Hamilton depression scale, seasonal affective disorder sub scale; NA: not applicable; NR: not reported; RR: Risk Ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹The trial has an unclear risk of bias. The effect is very imprecise because there are few participants in the trials.

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Fluoxetine compared with light therapy for seasonal affective disorder
Patient or population: Adults with seasonal affective disorder Settings: Outpatients Intervention: Fluoxetine Comparison: Light therapy
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Light therapy	Fluoxetine
Response (> 50% improvement on 24‐item HAM‐D SIGH‐SAD) Five to eight weeks	Medium risk population		RR 0.98 (0.77 to 1.24)	146 (2)	⊕⊕⊝⊝ low¹
	68 per 100	67 per 100 (52 to 87)
Remission (response plus end score eight or less) Five to eight weeks	Medium risk population		RR 0.81 (0.39 to 1.71)	146 (2)	⊕⊝⊝⊝ very low²
	68 per 100	55 per 100 (22 to 94)
Quality of life (SF‐20 & Q‐LES‐Q) Eight weeks	NR	NR	No significant differences	96 (1)	NA	No relative effect was calculated
Adverse effects (at least one treatment‐emergent adverse effect) Eight weeks	Medium risk population		RR 0.97 (0.78 to 1.22)	96 (1)	⊕⊝⊝⊝ very low³
	77 per 100	75 per 100 (60 to 94)
The basis for the assumed risk* (e.g. the median control group risk across studies) is the response rate in the light therapy groups in the two included trials. The corresponding risk (and its 95% CI) is based on the assumed risk in the fluoxetine group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; HAM‐D SIGH‐SAD: Hamilton depression scale, seasonal affective disorder sub scale; NA: not applicable; NR: not reported; Q‐LES‐Q: Quality of life enjoyment and satisfaction questionnaire; RR: Risk Ratio; SF‐20: medical outcome study
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹The trials provide direct evidence for average patients with SAD and use recommended doses of fluoxetine (directness). There was no inconsistency. The risk of bias in the two trials was low to moderate. Finally, the calculated effect is imprecise because there are few participants in the trials. ²The trials provide direct evidence for average patients with SAD and use recommended doses of fluoxetine (directness). There was serious inconsistency. The risk of bias in the two trials was low to moderate. Finally, the calculated effect is imprecise because there are few participants in the trials. ³The data are from only one trial with a low risk of bias, however, the outcome encompasses many adverse effects and therefore the data are indirect. Furthermore, the effect is imprecise because there are few participants in the trial.

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Table 1. Risk of bias table (non‐randomised study), Pjrek 2007

Domain	Authors' judgement	Support for judgement
How allocation occured? Concealment of allocation?	High risk	All patients received active therapy with escitalopram. No concealment of allocation
Blinding? (Participants)	High risk	Open‐label
Follow‐up equal and complete?	Low risk	10% attrition
Baseline comparability of groups?	Unclear	Only one group
ITT‐analysis	Low risk	ITT analysis employed
Intervention clearly specified?	Low risk	Intervention clearly described
Outcomes clearly specified?	Low risk	Outcomes clearly specified including prospective adverse events recording with Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale
Interpretation based on results?	Low risk	Yes

Table 1. Risk of bias table (non‐randomised study), Pjrek 2007

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Table 2. Risk of bias table (non‐randomised study), Pjrek 2008

Domain	Authors' judgement	Support for judgement
How allocation occured? Concealment of allocation?	High risk	All patients received active therapy with duloxetine. No concealment of allocation
Blinding? (Participants)	High risk	Open‐label
Follow‐up equal and complete?	High risk	23% attrition
Baseline comparability of groups?	Unclear	Only one group
ITT‐analysis	HIgh risk	LOCF analysis employed
Intervention clearly specified?	Low risk	Intervention clearly described
Outcomes clearly specified?	Low risk	Outcomes clearly specified including prospective adverse events recording with Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale
Interpretation based on results?	High risk	No, due to high attrition and use of LOCF approach for missing data

Table 2. Risk of bias table (non‐randomised study), Pjrek 2008

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Table 3. Risk of bias table (non‐randomised study), Pjrek 2009

Domain	Authors' judgement	Support for judgement
How allocation occured? Concealment of allocation?	High risk	All patients received active therapy with reboxetine. No concealment of allocation
Blinding? (Participants)	High risk	Open‐label
Follow‐up equal and complete?	High risk	27% attrition
Baseline comparability of groups?	Unclear	Only one group
ITT‐analysis	HIgh risk	LOCF analysis employed
Intervention clearly specified?	Low risk	Intervention clearly described
Outcomes clearly specified?	Low risk	Outcomes clearly specified including prospective adverse events recording with Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale
Interpretation based on results?	High risk	No, due to high attrition and use of LOCF approach for missing data

Table 3. Risk of bias table (non‐randomised study), Pjrek 2009

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Table 4. Adverse effects

Study ID	Lam 2006		Lam 1995		Prjek 2007	Pjrek 2008	Pjrek 2009
Study design	RCT		RCT		Open‐label observational study	Open‐label observational study	Open‐label observational study
SGA	Fluoxetine	Light therapy	Fluoxetine	Placebo	Escitalopram	Duloxetine	Reboxetine
Number of participants (N)	N=48	N= 48	N=36	N=32	N = 20	N=26	N= 15
Overall AEs (%)	75	77	97	91	55		100
Withdrawal due to AEs (%)	25	23	6	3		15.4	26.6
Gastrointestinal
Abdominal Pain (%)	8.3	6.3
Nausea (%)	10.4	4.2			40	53.8	20
Vomiting (%)
Diarrhoea (%)	10.4	4.2			5	23.1	0.0
Constipation (%)	6.3	8.3			5	11.5	26.7
Decreased appetite (%)	14.6	14.6			5		6.7
Increased appetite (%)	14.6	8.3				3.8
Weight loss (%)	6.3	2.1				3.8
Dyspepsia (%)
Central nervous system
Anxiety (%)	25.0	12.5
Nervousness (%)	10.4	12.5
Agitation (%)	12.5	0
Dizziness (%)					5		0.0
Tremor (%)	6.3	2.1				3.8	33.3
Irritability (%)	8.3	4.2
Sleepiness (%)	12.5	8.3				3.8	26.7
Increased sleep (%)	18.8	12.5					6.7
Decreased sleep (%)	20.8	22.9
Sleep disturbance (%)	29.2	2.1				7.7
Headache (%)	10.4	16.7			5	7.7	13.3
Paraesthesia (%)							20.0
Sexual Dysfunction
Decreased sex drive (%)	16.7	14.6			20		0
Male erection problems (%)	6.3	4.7
Female delayed orgasm (%)	6.3	0
Ejaculation* (%)
Other
Feeling faint (%)	0	6.3
Palpitations (%)	10.4	0				3.8	60.0
Sweating (%)	10.4	6.3				11.5	73.3
Flushing (%)	4.2	6.3
Muscle pain (%)	12.5	12.5
Weakness/fatigue (%)	16.7	16.5
Rash (%)	6.3	0
Dry mouth (%)	14.6	18.8				11.5	86.7
Hypersalivation (%)							6.7
Dry eyes (%)							6.7
Urinary retention (%)							6.7
Concentration problems (%)						3.8
Dilated pupils (%)						3.8
Emotional Indifference (%)						3.8
Photosensitivity (%)						3.8
Vivid dreams (%)						3.8
Psychomotor agitation (%)							73.3
Orthostatic dysregulation (%)							60.0
Accomodative dysfunction (%)							26.7

Table 4. Adverse effects

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Comparison 1. Fluoxetine versus Placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Response (> 50% improvement on 29‐item HAM‐D SIGH‐SAD) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Harm: Overall adverse effects Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 1. Fluoxetine versus Placebo

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Comparison 2. Fluoxetine versus Light Therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Response (> 50% improvement on 24‐item HAM‐D SIGH‐SAD) Show forest plot	2	136	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.77, 1.24]

2 Remission (response plus end score eight or less) Show forest plot	2	136	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.64, 1.30]

3 Harm: At least one treatment‐emergent adverse effect Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 Harm: Agitation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5 Harm: Sleep disturbance Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 Harm: Palpitations Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 2. Fluoxetine versus Light Therapy

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