Introduction
Bipolar disorder patients demonstrate a high rate of medication non-adherence which ranges anywhere between 20% to 60%. Long acting injectable (LAI) drugs are considered to possess the potential to manage this non-adherence and thereby, decrease the risk of suicide attempts and lower the expenditure of mental health care. Paliperidone palmitate has been proven to be effective and safe in acute manic or mixed episodes as observed in bipolar I disorder.
Objective
To assess the effectiveness, compliance and safety profile of once-monthly paliperidone palmitate in the management of bipolar I disorder.
Patients and Methods
11 bipolar I disorder patients, aged 16–65 years, were enrolled in an open-label, one-arm, prospective observational study. They were prescribed paliperidone palmitate monotherapy or paliperidone palmitate combination therapy.
Assessment Parameters
- Compliance with pharmaceutical treatment
- Symptomatic improvement
- Prevention of relapse or switch to another polarized affective episode
- Prevention of hospitalization
- Control of disturbing behaviour
- Restore of employment
Outcomes
- Relapse or switch
- Response
- Remission
Results
- At the baseline, all the participants were experiencing manic or mixed episodes; 63.6% were presented with psychotic features, 36.4% had encountered recent suicide attempts, 36.4% had abnormal glucose or lipid metabolism, 27.3% had experienced psychoactive substance abuse and 18.2% were suffering from thyroid diseases.
- While only 63.6% had experienced at least one depressive episode, all the participants had experienced at least one hypomania/mixed episode.
- 81.8% of the patients had received pharmaceutical treatment before being enrolled in the study.
- Only 3% of the participants were treated with paliperidone palmitate monotherapy while the others received combined treatment amongst which 18.2% received modified electroconvulsive therapy (MECT).
- It was observed that at the endpoint, 54.5% participants maintained paliperidone palmitate monotherapy and the others received lithium, alprazolam, or fluoxetine with paliperidone palmitate treatment.
- While 36.4% discontinued paliperidone palmitate treatment owing to efficacy reasons, 18.2% underwent discontinuation for personal reasons.
- A decrease in scores of Hamilton Depression Scale (HAMD-17), Young Mania Rating Scale (YMRS), and Clinical Global Impression—Bipolar Scale (CGI-BP) from the baseline (16.1 ± 10.3, 30.9 ± 12.6, 5.3 ± 0.7) to the endpoint (7.4 ± 5.7, 3.7 ± 3.2, 2.3 ± 0.7) was observed.
- There was no new report of hospitalization for any of the patients during the paliperidone palmitate treatment.
- While 27.3% of the patients experienced a mild to moderate depressive episode; no hypomanic episode was observed.
- No instance of abnormal behaviour was observed at the endpoint as opposed to 90.9% of the cases at the baseline.
- After the treatment, only 9.1% demonstrated deterioration in status of employment while all the others experienced an improvement.
- Significant difference in the final treatment outcome was found between the initial/final paliperidone palmitate monotherapy group and the initial/final paliperidone palmitate combined treatment group (P > 0.05)
- The duration of follow-up was notably longer in the final paliperidone palmitate monotherapy group.
- Common treatment-emergent adverse events (TEAEs) that were observed during paliperidone palmitate treatment were sedation (63.6%), weight gain (54.5%), prolactin related adverse events, decreased energy and insomnia (45.5%).
- Some of the other adverse effects that were observed were depressive mood, extrapyramidal symptoms, sickness and injection-site pain.
Conclusion
Paliperidone palmitate has the potential to be of use in the long-term management of bipolar I disorder as monotherapy or adjunctive therapy, specifically in patients with poor compliance with oral medication.