The effect of low dose lofepramine in depressed elderly patients in general medical wards.

Abstract

A double‐blind randomised controlled trial of the effect of low dose lofepramine (70 mg once daily) against placebo was carried out on depressed elderly inpatients on general medical wards for the elderly, comparing measures of depression and side‐effects between the randomised groups. Patients were identified for the study using the Geriatric Depression Scale (GDS) and the Brief Assessment Schedule Depression Cards (BASDEC). Sixty‐three subjects were randomised: 46 patients completed the entire trial of 28 days treatment. BASDEC and GDS were administered on day 8 post‐admission, and depressed patients were randomised double‐blind to either low dose lofepramine (70 mg daily) (n = 23) or placebo (n = 23). Assessment of changes in depressive states were made using the Montgomery Asberg Depression Rating Scale (MADRS) on days 8, 18 and 36 post‐admission. Both groups improved by a similar amount during the trial. Lofepramine tended to be more effective than placebo in those patients who were more depressed (GDS > or = 18). On the other hand, subjects who were less depressed (i.e. GDS < 18) improved more on placebo than lofepramine. Low dose lofepramine may prove useful in moderately or severely depressed patients treated for only 4 weeks. However, low dose lofepramine is not indicated for mild (GDS 15‐18) depression.

Efficacy of treatment in older depressed patients: A systematic review and meta-analysis of double-blind randomized controlled trials with antidepressants

“…Eighteen RCTs were excluded because no diagnostic criteria were used to diagnose depression (Branconnier et al, 1982(Branconnier et al, , 1983Burrows et al, 2002;Fairweather et al, 1993;Ghose, 1997;Goldstein et al, 1982;Kane et al, 1983;Kernohan et al, 1967;Kretschmar, 1979;Lakshmanan et al, 1986;Malsch et al, 1996;Middleton, 1975;Nugent, 1979;Passeri, 1987;Scardigli and Jans, 1982;Shapiro et al, 1960;Tan et al, 1994;Von Knorring, 1980). RCTs aimed at specific subgroups were not included to produce more homogeneous results: 7 studies including a majority of patients with dementia (Cunha et al, 2007;Lyketsos et al, 2003;Magai et al, 2000;Passeri et al, 1993;Petracca et al, 1996Petracca et al, , 2001Rosenberg et al, 2010), two in patients with dysthymia or minor depression (Devanand et al, 2005;Williams et al, 2000b) and one in patients with treatment-resistant depression (Sunderland et al, 1994).…”

A Systematic Review of Antidepressant Placebo-Controlled Trials for Geriatric Depression: Limitations of Current Data and Directions for the Future

“…Two of five (40%) studies with an entry age of 55, investigating a total of 70 subjects, reported negative results (Jarvik et al, 1982;Kane et al, 1983). In contrast, three of 12 studies (17%) with a minimum entry age of 60, investigating a total of 709 subjects, reported negative results on their primary outcome (Tan et al, 1994;Tollefson et al, 1995;Evans et al, 1997). One of these reported positive results on secondary outcomes (Tollefson et al, 1995).…”

“…The two studies in medical in-patients both failed to differentiate active drug from placebo (Tan et al, 1994;Evans et al, 1997). The two studies in nursing home populations found differing results (Katz et al, 1990;Burrows et al, 2002), but this was complicated as one examined minor rather than major depression (Burrows et al, 2002).…”

“…HAM-A found significantly greater improvement in the treatment group on two studies (Gerner et al, 1980;Branconnier et al, 1983). MADRS was used in only two studies (Tan et al, 1994;Halikas, 1995). Both reported negative results.…”

“…The other study examined low-dose lofepramine, a TCA used in Europe, in a small group of medical in-patients (Tan et al, 1994). This study included no HAM-D data.…”