Newer generation antidepressants for depressive disorders in children and adolescents - PubMed (original) (raw)

Review

Newer generation antidepressants for depressive disorders in children and adolescents

Sarah E Hetrick et al. Cochrane Database Syst Rev. 2012.

Abstract

Background: Depressive disorders are common in young people and are associated with significant negative impacts. Newer generation antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), are often used, however evidence of their effectiveness in children and adolescents is not clear. Furthermore, there have been warnings against their use in this population due to concerns about increased risk of suicidal ideation and behaviour.

Objectives: To determine the efficacy and adverse outcomes, including definitive suicidal behaviour and suicidal ideation, of newer generation antidepressants compared with placebo in the treatment of depressive disorders in children and adolescents.

Search methods: For this update of the review, we searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) to October 2011. The CCDANCTR includes relevant randomised controlled trials from the following bibliographic databases: CENTRAL (the Cochrane Central Register of Controlled Trials) (all years), EMBASE (1974 -), MEDLINE (1950 -) and PsycINFO (1967 -). We searched clinical trial registries and pharmaceutical company websites. We checked reference lists of included trials and other reviews, and sent letters to key researchers and the pharmaceutical companies of included trials from January to August 2011.

Selection criteria: Published and unpublished randomised controlled trials (RCTs), cross-over trials and cluster trials comparing a newer generation antidepressant with a placebo in children and adolescents aged 6 to 18 years old and diagnosed with a depressive disorder were eligible for inclusion. In this update, we amended the selection criteria to include newer generation antidepressants rather than SSRIs only.

Data collection and analysis: Two or three review authors selected the trials, assessed their quality, and extracted trial and outcome data. We used a random-effects meta-analysis. We used risk ratio (RR) to summarise dichotomous outcomes and mean difference (MD) to summarise continuous measures.

Main results: Nineteen trials of a range of newer antidepressants compared with placebo, containing 3335 participants, were included. The trials excluded young people at high risk of suicide and many co-morbid conditions and the participants are likely to be less unwell than those seen in clinical practice. We judged none of these trials to be at low risk of bias, with limited information about many aspects of risk of bias, high drop out rates and issues regarding measurement instruments and the clinical usefulness of outcomes, which were often variously defined across trials. Overall, there was evidence that those treated with an antidepressant had lower depression severity scores and higher rates of response/remission than those on placebo. However, the size of these effects was small with a reduction in depression symptoms of 3.51 on a scale from 17 to 113 (14 trials; N = 2490; MD -3.51; 95% confidence interval (CI) -4.55 to -2.47). Remission rates increased from 380 per 1000 to 448 per 1000 for those treated with an antidepressant. There was evidence of an increased risk (58%) of suicide-related outcome for those on antidepressants compared with a placebo (17 trials; N = 3229; RR 1.58; 95% CI 1.02 to 2.45). This equates to an increased risk in a group with a median baseline risk from 25 in 1000 to 40 in 1000. Where rates of adverse events were reported, this was higher for those prescribed an antidepressant. There was no evidence that the magnitude of intervention effects (compared with placebo) were modified by individual drug class.

Authors' conclusions: Caution is required in interpreting the results given the methodological limitations of the included trials in terms of internal and external validity. Further, the size and clinical meaningfulness of statistically significant results are uncertain. However, given the risks of untreated depression in terms of completed suicide and impacts on functioning, if a decision to use medication is agreed, then fluoxetine might be the medication of first choice given guideline recommendations. Clinicians need to keep in mind that there is evidence of an increased risk of suicide-related outcomes in those treated with antidepressant medications.

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Conflict of interest statement

Per Sindahl works at Leo Pharma A/S, however, his main areas are dermatology and critical care. He is not involved in psychiatric disorders.

There is no conflict of interest for any author.

Figures

1

1

Study flow diagram.

2

2

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

3

3

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

4

4

Funnel plot of comparison: 1 Newer generation antidepressant versus placebo (by medication), outcome: 1.2 Remission or response (as defined in trial) LOCF only.

5

5

Funnel plot of comparison: 1 Newer generation antidepressant versus placebo (by medication), outcome: 1.6 Suicide‐related outcome.

6

6

Contour‐enhanced funnel plot for the outcome remission or response (mix of OC and LOCF). The dashed vertical line represents the pooled random‐effects estimate

7

7

Contour‐enhanced funnel plot for the suicide‐related outcome. The dashed vertical line represents the pooled random‐effects estimate

8

8

Forest plot of comparison: 1 Second generation antidepressant versus placebo (by medication), outcome: 1.1 Depressive symptom severity (CDRS‐R).

1.1

1.1. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 1: Depressive symptom severity (CDRS‐R)

1.2

1.2. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 2: Remission or response (as defined in trial) LOCF only

1.3

1.3. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 3: Remission or response (as defined in trial) mix OC and LOCF

1.4

1.4. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 4: Depressive symptom severity self rated

1.5

1.5. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 5: Functioning CGAS

1.6

1.6. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 6: Suicide‐related outcome

1.7

1.7. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 7: Suicidal ideation SIQ‐JR

1.8

1.8. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 8: Adverse events

1.9

1.9. Analysis

Comparison 1: Newer generation antidepressant versus placebo (by drug), Outcome 9: Completion of trial protocol

2.1

2.1. Analysis

Comparison 2: Newer generation antidepressant versus placebo (child vs adolescent), Outcome 1: Depressive symptom severity (CDRS‐R)

2.2

2.2. Analysis

Comparison 2: Newer generation antidepressant versus placebo (child vs adolescent), Outcome 2: Remission or response (as defined in trial)

2.3

2.3. Analysis

Comparison 2: Newer generation antidepressant versus placebo (child vs adolescent), Outcome 3: Depressive symptom severity self rated

2.4

2.4. Analysis

Comparison 2: Newer generation antidepressant versus placebo (child vs adolescent), Outcome 4: Functioning CGAS

2.5

2.5. Analysis

Comparison 2: Newer generation antidepressant versus placebo (child vs adolescent), Outcome 5: Suicide‐related outcome

2.6

2.6. Analysis

Comparison 2: Newer generation antidepressant versus placebo (child vs adolescent), Outcome 6: Adverse events

Update of

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