Comparative effectiveness of continuation and maintenance treatments for persistent depressive disorder in adults

Katja Machmutow; Ramona Meister; Alessa Jansen; Levente Kriston; Birgit Watzke; Martin Christian Härter; Sarah Liebherz

doi:10.1002/14651858.CD012855.pub2

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Figure 1

Study flow diagram. NRCT: non‐randomized controlled trial; PDD: persistent depressive disorder; RCT: randomized controlled trial.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included seven randomized controlled trials. Blank space in rows containing no information indicate missing information on the 'Risk of bias' scale for the three non‐randomized controlled trials.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included randomized controlled trial (seven studies). Blank space in rows containing no information indicate missing information on the 'Risk of bias' scale for the three non‐randomized controlled trials.

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Figure 4

Risk of bias graph non‐randomized controlled trials (NRCT): review authors' judgement about each risk of bias item presented as percentages across all included NRCTs (three studies).

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Figure 5

Risk of bias summary non‐randomized controlled trials (NRCT): review authors' judgements about each risk of bias item for each included NRCT (three studies).

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Figure 6

Forest plot of comparison: 1 Medication versus placebo, outcome: 1.1 Relapse/recurrence.

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Analysis 1.1

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 1 Relapse/recurrence.

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Analysis 1.2

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 2 Dropout due to any reason.

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Analysis 1.3

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 3 Depression severity.

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Analysis 1.4

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 4 SF‐36 Social Functioning score.

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Analysis 1.5

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 5 SF‐36 Emotional Role score.

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Analysis 1.6

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 6 SF‐36 Role Physical score.

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Analysis 1.7

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 7 Dropout due to any type of adverse event.

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Analysis 1.8

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 8 Any type of adverse event.

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Analysis 1.9

Comparison 1 Pharmacological continuation and maintenance therapies versus placebo, Outcome 9 Relapse/recurrence sensitivity analysis.

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Analysis 2.1

Comparison 2 Psychological continuation and maintenance therapies versus attention placebo/non‐specific control, Outcome 1 Relapse/recurrence.

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Analysis 2.2

Comparison 2 Psychological continuation and maintenance therapies versus attention placebo/non‐specific control, Outcome 2 Dropout due to any reason.

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Analysis 2.3

Comparison 2 Psychological continuation and maintenance therapies versus attention placebo/non‐specific control, Outcome 3 Depression severity.

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Analysis 3.1

Comparison 3 Psychological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies, Outcome 1 Relapse/recurrence.

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Analysis 3.2

Comparison 3 Psychological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies, Outcome 2 Dropout due to any reason.

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Analysis 4.1

Comparison 4 Combined psychological and pharmacological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies alone, Outcome 1 Relapse/recurrence.

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Analysis 4.2

Comparison 4 Combined psychological and pharmacological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies alone, Outcome 2 Dropout due to any reason.

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Analysis 4.3

Comparison 4 Combined psychological and pharmacological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies alone, Outcome 3 Depression severity.

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Analysis 4.4

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Analysis 4.5

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Analysis 4.6

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Analysis 5.1

Comparison 5 Combined psychological and pharmacological continuation and maintenance therapies versus psychotherapeutic continuation and maintenance therapies alone, Outcome 1 Relapse/recurrence.

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Analysis 5.2

Comparison 5 Combined psychological and pharmacological continuation and maintenance therapies versus psychotherapeutic continuation and maintenance therapies alone, Outcome 2 Dropout due to any reason.

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Analysis 6.1

Comparison 6 Imipramine (TCA) versus desipramine (TCA), Outcome 1 Dropout due to any reason.

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Analysis 6.2

Comparison 6 Imipramine (TCA) versus desipramine (TCA), Outcome 2 Dropout due to any type of adverse event.

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Analysis 7.1

Comparison 7 Imipramine (TCA) versus sertraline (SSRI), Outcome 1 Relapse/recurrence.

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Analysis 7.2

Comparison 7 Imipramine (TCA) versus sertraline (SSRI), Outcome 2 Dropout due to any reason.

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Analysis 7.3

Comparison 7 Imipramine (TCA) versus sertraline (SSRI), Outcome 3 Depression severity.

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Analysis 7.4

Comparison 7 Imipramine (TCA) versus sertraline (SSRI), Outcome 4 Health‐related quality of life.

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Analysis 7.5

Comparison 7 Imipramine (TCA) versus sertraline (SSRI), Outcome 5 Dropout due to any type of adverse event.

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Pharmacological continuation and maintenance treatment compared with placebo for persistent depressive disorder
Patient or population: people with persistent depressive disorder Settings: outpatient treatment Intervention: pharmacological continuation or maintenance treatment (sertraline, phenelzine, nefazodone, desipramine) Comparison: tablet 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	Pharmacotherapy
Relapse/recurrence (end of intervention)	338 per 1000	139 per 1000^a (71 to 267)	RR 0.41 (0.21 to 0.79)	383 (4 studies)	⊕⊕⊕⊝^b Moderate	See Characteristics of included studies table for the criteria of relapse/recurrence.
Dropout due to any reason (end of intervention)	255 per 1000	230 per 1000^a (99 to 538)	RR 0.90 (0.39 to 2.11)	386 (4 studies)	⊕⊕⊝⊝^{c, d} Low	"Dropout due to any reason" was all reported dropouts due to other reasons than relapse/recurrence. 1 study only reported dropouts in the first month of the maintenance treatment phase (Kocsis 1996). As the maintenance treatment lasted 24 months, the dropout rate in this study was very likely to be underestimated.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; 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.
^aAssumed risk calculated as the proportion of participants on placebo with the outcome (relapse/recurrence or dropout any) in the four included studies, multiplied by 1000. ^bDowngraded due to limitations in the design and implementation of available studies suggesting high likelihood of bias (there were studies with high or unclear risk of bias in almost all RoB‐Domains (except detection bias)). ^cDowngraded due to unexplained heterogeneity between studies (I² = 64%). Due to the small number of included studies, subgroup or meta‐regression analyses were not performed. In two studies, dropout rates were higher in the intervention group, in two studies they were lower. ^dDowngraded due to imprecision of results (the overall confidence interval was wide and the confidence intervals of two included studies are also very wide).

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Table 1. Overview of included studies

Related acute‐phase study	Study ID	Treatment arms	Continuation/maintenance (treatment duration)	Study design	Diagnosis
Keller 1998b	Koran 2001	Sertraline Imipramine	Continuation (16 weeks)	NRCT	Chronic major depressive disorder, double depression
Keller 1998b	Keller 1998b	Sertraline Placebo	Maintenance (76 weeks)	RCT	Chronic major depressive disorder, double depression
Harrison 1986	Harrison 1986	Phenelzine Placebo	Continuation (26 weeks)	RCT	Dysthymia, double depression
Keller 2000	Kocsis 2003	Nefazodone CBASP Combination	Continuation (16 weeks)	NRCT	Chronic major depressive disorder, double depression, recurrent depressive disorder with incomplete interepisode remission
	Gelenberg 2003	Nefazodone Placebo	Maintenance (52 weeks)	RCT	Chronic major depressive disorder, double depression, recurrent depressive disorder with incomplete interepisode remission
	Klein 2004	CBASP Assessment only	Maintenance (52 weeks)	RCT	Chronic major depressive disorder, double depression, recurrent depressive disorder with incomplete interepisode remission
Hellerstein 2001	Hellerstein 2001	Fluoxetine Fluoxetine + group psychotherapy	Continuation (16 weeks)	RCT	Dysthymia
Marin 1994	Kocsis 1995	Imipramine Desipramine	Continuation (16–20 weeks)	NRCT	Dysthymia, double depression
	Kocsis 1996*	Desipramine Placebo	Maintenance (104 weeks)	RCT	Chronic major depressive disorder, dysthymia, double depression
	Miller 2001*	Desipramine Placebo	Maintenance (104 weeks)	RCT	Dysthymia
*These groups are partially overlapping (see above). CBASP: Cognitive Behavioral Analysis System of Psychotherapy; NRCT: non‐randomized controlled trial; RCT: randomized controlled trial.

Table 1. Overview of included studies

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Table 2. Risk of bias (non‐randomized trials) – Kocsis 1995

Risk of bias (ROBINS‐I tool)	Rating	Explanation of judgement	Possible ratings
Bias due to confounding	5	No information how participants were allocated to groups in the acute treatment.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in selection of participants into the study	2	Different length of drugs and procedures during acute treatment (participants of 3 protocols were included for analyses of continuation treatment).	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in classification of interventions	1	Intervention was well defined: IMI and DMI were continued on an open basis at the same final dose achieved during the acute phase.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias due to departures from intended interventions	1	No indication for departures from intended interventions, check of plasma levels was performed.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias due to missing data	2	Proportions of missing participants differed substantially across interventions: 26% in the IMI group and 6% in the DMI group, in the IMI group 4 participants did not comply with the follow‐up assessment, reasons for dropout were reported; but proportion of dropout due to dissatisfaction with treatment was similar for IMI and DMI (7% and 6%).	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in measurement of outcomes	3	Participants in the IMI protocols were seen and rated once at week 26 of treatment. Participants on the DMI protocol were seen and rated every 2 weeks through week 26. Lack of blinding: participants and raters were aware of the treatment. (see p. 214)	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in selection of the reported result	3	Not all predefined outcomes were reported separately for both groups. Some data were assessed every 2 weeks, these data were not reported. In general, data were not reported for HAM‐D and GAS for the DMI vs IMI.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
DMI: desipramine; GAS: Global Assessment Scale; HAM‐D: Hamilton Depression Rating Scale; IMI: imipramine.

Table 2. Risk of bias (non‐randomized trials) – Kocsis 1995

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Table 3. Risk of bias (non‐randomized trials) – Kocsis 2003

Risk of bias (ROBINS‐I tool)	Rating	Explanation of judgement	Possible ratings
Bias due to confounding	1	Randomization before acute phase, exclusion of cross‐over participants.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in selection of participants into the study	1	All eligible participants were included, cross‐over participants were excluded; acute phase treatment had the same length and measurement times for all groups.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in classification of interventions	1	Intervention status was well described (planned and actual dose of medication as well as number of CBASP sessions).	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias due to departures from intended interventions	1	Medication doses as well as number of CBASP sessions were within the planned range.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias due to missing data	1	Number of missing data was low and comparable in all groups (2–3%).	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in measurement of outcomes	1	Methods of outcome assessment were comparable across intervention groups. Quote: "Trained independent evaluators unaware of treatment assignment completed the HAM‐D‐24 at each assessment visit." (p. 77), no means and standard deviations reported, unclear if other subscales were evaluated.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in selection of the reported result	2	No study protocol existed, but all measures mentioned in the methods section were reported in the outcome section.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
CBASP: Cognitive Behavioral Analysis System of Psychotherapy; HAM‐D: Hamilton Depression Rating Scale.

Table 3. Risk of bias (non‐randomized trials) – Kocsis 2003

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Table 4. Risk of bias (non‐randomized trials) – Koran 2001

Risk of bias (ROBINS‐I tool)	Rating	Explanation of judgement	Possible ratings
Bias due to confounding	1	Randomization before acute phase.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in selection of participants into the study	1	All possible participants were included (direct and cross‐over). All measures existing from the beginning of the intervention. The study flow was clearly described since acute treatment.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in classification of interventions	1	Intervention status is well defined (dose ranges are described in section 2.3 and 3.4).	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias due to departures from intended interventions	1	Assignment to intervention. Quote: "For both treatment groups, 10% of patients had dose increases aimed at improving outcome" (p. 31); same for both groups with regard to the main outcome; adapting dose is usual practice; no deviation from intended treatment, they counted the tablets.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias due to missing data	1	Quote: "For all patients, including drop outs, pill counts indicated compliance rates of 88.7% for imipramine and 84.7% for sertraline. No differences were found between diagnostic groups or between acute and crossover patients." (p. 31); Proportions of and reasons for missing participants were similar across intervention groups; less than 5% dropout for the main outcome; proportions of missing data were comparable and are addressed in the analyses with LOCF.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in measurement of outcomes	1	Information from Rush et al., 1998 (study protocol): reliable ratings (p. 593); quote: "continued on the same double‐blind medication dose for an additional 16 weeks" (p. 593); assessment methods comparable across groups.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
Bias in selection of the reported result	2	Outcomes correspond to the ones named in the protocol, but protocol just for acute phase; not all measures used during the acute phase were used in continuation phase.	Code 1 = low risk, 2 = moderate risk, 3 = serious risk, 4 = critical risk, 5 = no information
LOCF: last observation carried forward.

Table 4. Risk of bias (non‐randomized trials) – Koran 2001

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Comparison 1. Pharmacological continuation and maintenance therapies versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relapse/recurrence Show forest plot	4	383	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.21, 0.79]

2 Dropout due to any reason Show forest plot	4	386	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.39, 2.11]

3 Depression severity Show forest plot	3	333	Mean Difference (IV, Random, 95% CI)	‐4.79 [‐8.49, ‐1.09]

4 SF‐36 Social Functioning score Show forest plot	1	161	Mean Difference (IV, Random, 95% CI)	10.80 [3.04, 18.56]

5 SF‐36 Emotional Role score Show forest plot	1	161	Mean Difference (IV, Random, 95% CI)	20.70 [7.43, 33.97]

6 SF‐36 Role Physical score Show forest plot	1	161	Mean Difference (IV, Random, 95% CI)	2.10 [‐9.76, 13.96]

7 Dropout due to any type of adverse event Show forest plot	3	333	Odds Ratio (M‐H, Random, 95% CI)	3.53 [0.67, 18.70]

8 Any type of adverse event Show forest plot	1	161	Odds Ratio (M‐H, Random, 95% CI)	1.47 [0.70, 3.09]

9 Relapse/recurrence sensitivity analysis Show forest plot	4	360	Risk Ratio (M‐H, Random, 95% CI)	0.38 [0.16, 0.89]

Comparison 1. Pharmacological continuation and maintenance therapies versus placebo

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Comparison 2. Psychological continuation and maintenance therapies versus attention placebo/non‐specific control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relapse/recurrence Show forest plot	1	82	Risk Ratio (M‐H, Random, 95% CI)	0.37 [0.14, 0.93]

2 Dropout due to any reason Show forest plot	1	82	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.41, 1.81]

3 Depression severity Show forest plot	1	82	Mean Difference (IV, Random, 95% CI)	‐4.00 [‐7.05, ‐0.95]

Comparison 2. Psychological continuation and maintenance therapies versus attention placebo/non‐specific control

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Comparison 3. Psychological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relapse/recurrence Show forest plot	1	176	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.43, 3.49]

2 Dropout due to any reason Show forest plot	1	179	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.30, 1.03]

Comparison 3. Psychological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies

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Comparison 4. Combined psychological and pharmacological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relapse/recurrence Show forest plot	1	238	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.44, 3.44]

2 Dropout due to any reason Show forest plot	2	280	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.90, 2.29]

3 Depression severity Show forest plot	1	39	Mean Difference (IV, Random, 95% CI)	2.8 [0.38, 5.22]

4 Depression severity – follow‐up Show forest plot	1	39	Mean Difference (IV, Random, 95% CI)	0.90 [‐3.26, 5.06]

5 Health‐related quality of life Show forest plot	1	35	Mean Difference (IV, Random, 95% CI)	‐0.5 [‐1.63, 0.63]

6 Health‐related quality of life – follow‐up Show forest plot	1	33	Mean Difference (IV, Random, 95% CI)	0.60 [‐0.56, 1.76]

Comparison 4. Combined psychological and pharmacological continuation and maintenance therapies versus pharmacological continuation and maintenance therapies alone

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Comparison 5. Combined psychological and pharmacological continuation and maintenance therapies versus psychotherapeutic continuation and maintenance therapies alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relapse/recurrence Show forest plot	1	234	Risk Ratio (M‐H, Random, 95% CI)	1.51 [0.57, 4.01]

2 Dropout due to any reason Show forest plot	1	238	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.45, 1.51]

Comparison 5. Combined psychological and pharmacological continuation and maintenance therapies versus psychotherapeutic continuation and maintenance therapies alone

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Comparison 6. Imipramine (TCA) versus desipramine (TCA)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dropout due to any reason Show forest plot	1	73	Risk Ratio (M‐H, Random, 95% CI)	4.35 [1.19, 15.87]

2 Dropout due to any type of adverse event Show forest plot	1	73	Odds Ratio (M‐H, Random, 95% CI)	1.49 [0.23, 9.60]

Comparison 6. Imipramine (TCA) versus desipramine (TCA)

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Comparison 7. Imipramine (TCA) versus sertraline (SSRI)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Relapse/recurrence Show forest plot	1	376	Risk Ratio (M‐H, Random, 95% CI)	1.27 [0.84, 1.91]

2 Dropout due to any reason Show forest plot	1	386	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.48, 1.38]

3 Depression severity Show forest plot	1	377	Mean Difference (IV, Random, 95% CI)	0.40 [‐0.97, 1.77]

4 Health‐related quality of life Show forest plot	1	347	Mean Difference (IV, Random, 95% CI)	‐4.30 [‐7.31, ‐1.29]

5 Dropout due to any type of adverse event Show forest plot	1	386	Odds Ratio (M‐H, Random, 95% CI)	1.99 [0.60, 6.65]

Comparison 7. Imipramine (TCA) versus sertraline (SSRI)

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