Maintenance study for adolescent depression

During acute treatment, one trial openly treated all participants with sertraline and two others with fluoxetine.

“During the acute phase of treatment, one trial openly treated all participants with sertraline (Cheung 2008) and two others treated participants with fluoxetine (Emslie 2008; Kennard 2008).”

In the other two trials, acute phase treatment lasted 9-12 weeks, followed by continuation of 10-24 weeks, then maintenance and re-randomisation.

“In the other two trials, acute phase treatment lasted between 9 and 12 weeks, followed by a continuation phase of between 10 (Emslie 2004) and 24 weeks (Cheung 2008), after which participants entered a maintenance phase and again, were re-randomised into a potentially new treatment arm.”

Four trials contained continuation or maintenance phases specifically designed to prevent relapse-recurrence after initial response.

“Four trials contained continuation or maintenance phases (or both) specifically designed to prevent relapse-recurrence after initial response, and involved only those participants who had responded or remitted after an acute phase of treatment (Cheung 2008; Emslie 2004; Emslie 2008; Kennard 2008).”

Sample sizes in acute phase ranged 66-219; in relapse-prevention phase ranged 22-102.

“Sample sizes in the acute phase of treatment ranged from 66 (Kennard 2008) to 219 participants (Emslie 2004), and in the relapse-prevention phase ranged from 22 (Cheung 2008) to 102 participants (Emslie 2008).”

Three trials (Cheung 2008; Emslie 2004; Emslie 2008) provided data suitable for at least one outcome in the meta-analysis.

“Three trials (Cheung 2008; Emslie 2004; Emslie 2008) provided data suitable for at least one outcome in the meta-analysis.”

During relapse-prevention, three trials compared medication with placebo and one compared combination therapy with medication alone.

“During the relapse prevention phase, three trials compared medication with a placebo pill (Cheung 2008; Emslie 2004; Emslie 2008) and one trial compared a combination of psychotherapy and medication with medication alone (Kennard 2008).”

These maintenance phases lasted between 36 and 52 weeks.

“These maintenance phases lasted between 36 (Emslie 2004) and 52 weeks (Cheung 2008).”

In Cheung 2008, sertraline was administered at 25-200 mg/day depending on response.

“In the trial by Cheung 2008, sertraline was administered at a dose of between 25 and 200 mg/day depending on response, by the treating clinician.”

Blinding of outcome assessor in Cheung 2008 was at low risk of bias.

“...clinicians and research staff remained blinded to treatment during the ran- domisation phase”

Blinding of participants/care providers in Cheung 2008 was at low risk of bias.

“Participants...remained blinded to treatment during the randomisation phase”

In Cheung 2008, reasons for drop-out in each group were reported, indicating low risk of attrition bias.

“Sertraline: 1 participant lost to follow-up Placebo: 1 participant lost to follow-up and 1 withdrew consent”

In Cheung 2008, the small sample size limits generalisation, and the study only included adolescents with MDD and did not capture the full spectrum of depressive disorders present in this age group.

“Small sample size limits generalisation. Only included adolescents with MDD and did not capture the full spectrum of depressive disorders present in this age group.”

In Cheung 2008, the ITT analysis was at low risk of attrition bias.

“Subjects who were randomised and received at least one dose of treat- ment/placebo were included in the analyses”

In Cheung 2008, 6 participants discontinued the study during the acute and continuation phases due to adverse effects: agitation and hostility (n=2), psychosis (n=1) and mania (n=3).

“6 participants discontinued the study during the acute and continuation phases due to adverse effects. Reasons for drop-out were: agitation and hostility (n = 2), psychosis (n = 1) and mania (n = 3).”

The random sequence generation in Cheung 2008 was at low risk of bias.

“Randomization was conducted by the study pharmacist using a comput- er-generated randomisation schedule”

In Cheung 2008, the number of drop-outs in each group was reported, indicating low risk of attrition bias.

“Number randomised in maintenance phase: sertraline = 13; placebo = 9; total = 22 Number of drop-outs during maintenance phase: sertraline = 1; placebo = 2; total = 3”