A double‐blind randomized placebo‐controlled study of the efficacy and safety of pirlindole, a reversible monoamine oxidase A inhibitor, in the treatment of depression

Abstract

The efficacy and safety of pirlindole (300 mg/day), a new reversible inhibitor of monoamine oxidase A, have been evaluated in a multicentre placebo-controlled double-blind randomized trial in 103 in-patients suffering from unipolar major depression (DSM-III-R 296.2, 296.3) over a 42-day period after a run-in placebo period of 6 days. Pirlindole produced a significantly greater decrease than placebo in the Hamilton depression score (from day 28), the Hamilton anxiety score (from day 28) and the Montgomery-Asberg depression score (on day 42). On day 42, the Hamilton depression score was < or = 7, > or = 8 and < or = 15, or > or = 16 in 21%, 45% and 34%, respectively, in the placebo group compared to 72%, 24% and 3.4%, respectively, in the pirlindole group (P < 0.001). The differences between the two groups in terms of tolerance and safety were not statistically significant.

Double‐blind randomized controlled study of the efficacy and tolerability of two reversible monoamine oxidase A inhibitors, pirlindole and moclobemide, in the treatment of depression

“…However, the frequency of dry mouth and tachycardia was significantly greater in the moclobemide group (19% and 15%, respectively) compared to the pirlindole group (6% and 4%, respectively). These results confirm the findings of the most recent study conducted with pirlindole vs. placebo, in which the frequency of dry mouth and tachycardia associated with pirlindole treatment was 2% and 0%, respectively (20). They also confirm the findings of the majority of studies conducted with moclobemide, in which the frequency of tachycardia ranges from 5 % (28) to 11% (29), and the frequency of dry mouth ranges from 17% (30) to 33% (29).…”

“…Pirlindole is a tetracyclic compound that has been characterized as a potential antidepressant drug in preclinical studies (16)(17)(18), and in which interest has been shown due to its marked selectivity as a RIMA (19). In clinical trials, the efficacy and safety of pirlindole have been demonstrated compared to placebo (20) and to reference standard drugs such as maprotiline (21), imipramine (22, 23), amitriptyline (23)(24)(25), desipramine (26) and mianserin (27).…”

Compliance to Long-Term Treatment of Cardiologic Patients With Mild to Moderate Depression: Ineffectiveness of Antidepressive Therapy With Pirlindol in Randomized Study

“…Безопасность и эффективность антидепрессивной те-рапии пирлиндолом неоднократно подтверждалась в различных зарубежных и отечественных исследованиях, в том числе, и среди пациентом с кардиальной пато-логией [6,9]. Однако попытка терапии депрессий лег-кой и умеренной степеней тяжести у пациентов с сер-дечно-сосудистыми заболеваниями антидепрессан-том пирлиндол как вмешательства, направленного на повышение приверженности этих пациентов к лечению препаратами кардиологического профиля ранее не производилась, в связи с чем опыта применения с этой целью антидепрессантов вообще, и пирлиндола в частности, нет.…”

“…Однако попытка терапии депрессий лег-кой и умеренной степеней тяжести у пациентов с сер-дечно-сосудистыми заболеваниями антидепрессан-том пирлиндол как вмешательства, направленного на повышение приверженности этих пациентов к лечению препаратами кардиологического профиля ранее не производилась, в связи с чем опыта применения с этой целью антидепрессантов вообще, и пирлиндола в частности, нет. Считается, что для эффективной анти-депрессивной терапии требуется лечение в течение 4-6 мес (минимум) [5,6,9]. В нашем исследовании в тече-ние 1 мес антидепрессивную терапию продолжили 24 (75%) пациента, в течение 2 мес -2 (6%).…”

Pirlindole and dehydropirlindole protect rat cultured neuronal cells against oxidative stress‐induced cell death through a mechanism unrelated to MAO‐A inhibition

“…Pirlindole (PIR, pirazidole; 1,10‐trimethylene‐8‐methyl‐1,2,3,4‐tetrahydropyrazino [1,2,‐a] indole hydrochloride) is a tetracyclic compound that has been characterized as a potential antidepressant drug (de wilde et al ., 1996; Bruhwyler et al ., 1997; Tanghe et al ., 1997). The main mechanism of action of PIR consists of a selective and reversible inhibition of the MAO type A (MAO‐A) (Medvedev et al ., 1992; 1996; Bruhwyler et al ., 1997).…”