What is the evidence for adding pramipexole to cariprazine for the management of dopaminergic side effects?

Comment by InpharmD Researcher

The available evidence for adding pramipexole to antipsychotic therapy for management of dopaminergic adverse effects is limited to adult populations, and no data exist evaluating pramipexole in combination with cariprazine specifically. Guidance generally supports discontinuation of the offending antipsychotic as the preferred approach to drug-induced parkinsonism; however, a single case report notes that such changes may be difficult in complex psychiatric presentations and suggests pramipexole as a potential option in those circumstances, although in the reported case, the antipsychotic was withdrawn before pramipexole was started, leaving the effect of true combination therapy unknown. Small open-label data indicate that low-dose pramipexole may reduce antipsychotic-induced parkinsonism, while effects on akathisia are inconsistent and mood symptoms may worsen in some individuals. Randomized trials in broader schizophrenia populations found variable symptom outcomes and do not demonstrate a consistent increase in extrapyramidal symptoms (EPS), although baseline EPS burden was low and follow-up periods were short, limiting the ability to detect differences. Overall, the evidence for combination use is sparse and indirect, with no data in pediatric patients. It is uncertain whether findings with other antipsychotics can be extrapolated to cariprazine, warranting cautious clinical consideration.

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Background

A 2022 case report describes a 51-year-old woman with bipolar I disorder and obsessive compulsive disorder receiving long-term antipsychotics and valproate who developed parkinsonian symptoms during admission for bipolar depression. Neurologic evaluation including a negative DaTSCAN supported a pharmacologic cause. Lurasidone was discontinued and pramipexole was initiated. Improvement in parkinsonian symptoms and remission of depressive symptoms were observed. The authors note that while guidelines recommend discontinuing or switching the causative agent, this may not always be feasible in complex psychiatric cases, and suggest pramipexole may be considered in the management of drug induced parkinsonism, particularly in patients with comorbid depressive disorders, while acknowledging that further research is needed. Of note, the antipsychotic was discontinued before pramipexole was initiated in this case, making it uncertain whether combination use would produce the same extent of effect. [1]

A 2012 randomized, double-blind, placebo-controlled pilot trial evaluated adjunctive pramipexole in 24 adults (43.3 ± 12.2 years) with DSM-IV schizophrenia or schizoaffective disorder receiving stable second-generation antipsychotics at ≥240 mg/day chlorpromazine equivalents, including risperidone, olanzapine, quetiapine, clozapine, and ziprasidone. Pramipexole, a preferential dopamine D3 agonist with D2 activity, was titrated over 6 weeks to a mean final dose of 4.25 ± 0.38 mg/day and continued for up to 12 weeks while background antipsychotic therapy was maintained. Adjunctive pramipexole was associated with greater reductions in Positive and Negative Symptom Scale (PANSS) total scores compared with placebo (−10.2% vs −4.9%, p= 0.044) and greater improvement in PANSS positive symptoms (−19.0% vs +7.2%, p= 0.006). Changes in negative symptoms were not statistically significant. Extrapyramidal symptoms (EPS) were assessed using the Simpson–Angus, Barnes Akathisia, and Abnormal Involuntary Movements (AIMS) scales; baseline scores were low, and no significant between-group differences were observed. The authors noted limited statistical power to detect differences in extrapyramidal or mood symptoms. Adverse effects included disorganized thinking, erectile dysfunction, increased auditory hallucinations, dizziness, and modest weight gain in a minority of patients. [2]

Additional studies have evaluated adjunctive pramipexole in patients with schizophrenia receiving ongoing antipsychotic therapy. In a 1997 open-label trial (n= 15), pramipexole was added to stable haloperidol (oral 5 to 20 mg/day or depot formulations) and titrated up to 10.25 mg/day over 2 weeks, with maintenance through day 28. Nine of 15 patients achieved >20% reduction in PANSS total score (22% to 62% reduction). Three patients discontinued due to worsening positive symptoms. Insomnia was the most frequent adverse effect (4 patients). EPS were assessed using the Simpson–Angus and Hillside Akathisia scales; no worsening from baseline was observed, and no clinically relevant cardiovascular, electrocardiographic, or laboratory abnormalities were reported. In a separate 16-week randomized, double-blind, placebo-controlled trial (n= 200), pramipexole 0.75 mg twice daily was added to stable antipsychotic regimens in patients with schizophrenia or schizoaffective disorder. Compared with placebo, pramipexole did not produce significant differences in PANSS total, positive, negative, or general psychopathology scores at weeks 8 or 16, and no significant differences were observed in Clinical Global Impressions–Severity of Illness scale (CGI-S) or cognitive outcomes. Extrapyramidal effects were infrequent in both groups, with no significant between-group differences on Simpson–Angus ratings. Of note, cariprazine was not among the antipsychotics included in this trial. Collectively, these studies describe pramipexole administered concomitantly with antipsychotics, with variable effects on symptom outcomes and no clear evidence of exacerbation of extrapyramidal or other dopaminergic adverse effects within the small samples and short duration studied. [3], [4]

References: [1] Bueno Sanya L, Bermejo Pastor A, Andreu Gracia H, De Juan Viladegut O, Olivier Mayorga L, Pacchiarotti I. The use of pramipexole in drug-induced parkinsonism: A case study on a patient with bipolar depression. Eur Psychiatry. 2022;65(Suppl 1):S411-S412. Published 2022 Sep 1. doi:10.1192/j.eurpsy.2022.1044
[2] Kelleher JP, Centorrino F, Huxley NA, et al. Pilot randomized, controlled trial of pramipexole to augment antipsychotic treatment. Eur Neuropsychopharmacol. 2012;22(6):415-418. doi:10.1016/j.euroneuro.2011.10.002
[3] Levi L, Zamora D, Nastas I, et al. Add-On Pramipexole for the Treatment of Schizophrenia and Schizoaffective Disorder: A Randomized Controlled Trial. J Clin Psychiatry. 2022;83(5):21m14233. Published 2022 Aug 1. doi:10.4088/JCP.21m14233
[4] Kasper S, Barnas C, Heiden A, et al. Pramipexole as adjunct to haloperidol in schizophrenia. Safety and efficacy. Eur Neuropsychopharmacol. 1997;7(1):65-70. doi:10.1016/s0924-977x(96)00393-8
Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

What is the evidence for adding pramipexole to cariprazine for the management of dopaminergic side effects?

Level of evidence

D - Case reports or unreliable data  Read more→



Please see Table 1 for your response.


Efficacy of low-dose D2/D3 partial agonist pramipexole on neuroleptic-induced extrapyramidal symptoms and symptoms of schizophrenia: a stage-1 open-label pilot study

Design

Stage-1 open-label pilot study

N= 10

Objective

To analyze whether a low dose of pramipexole (0.375–0.75 mg/day) has efficacy on extrapyramidal symptoms (EPS) and symptoms of schizophrenia while maintaining tolerability

Study Groups

All subjects (N= 10)

Inclusion Criteria

Patients 18–65 years of age; met DSM-IV criteria for drug-induced parkinsonian and akathisia; 6-item Simpson–Angus Scale (SAS) total score above 2 or a score of 2 or above on the global subscale of Barnes Akathisia Rating Scale (BARS)

Exclusion Criteria

Serious adverse event (death, rehospitalization, physical disability); poor compliance, protocol violation, or not taking drugs continuously for 4 days; scored mild on at least two Abnormal Involuntary Movement Scale (AIMS) items or moderate on one item considered to be tardive dyskinesia

Methods

Patients with drug induced parkinsonism and or akathisia received low dose pramipexole (0.375 mg/day in week 1, increased to 0.75 mg/day thereafter at investigator discretion) while continuing their existing antipsychotic regimens. Antipsychotics used included risperidone, aripiprazole, quetiapine, clozapine, olanzapine, amisulpride, and fluphenazine decanoate. EPS severity was assessed over time using SAS and BARS.

Duration

8 weeks

Outcome Measures

Primary: Relief of antipsychotic-induced parkinsonism

Secondary: Effect on psychiatric and mood symptoms of schizophrenia

Baseline Characteristics  

All subjects (N= 10)

Age, years

51.4 ± 14.7

Female

2 (20%)

Illness duration, years

20.6 ± 14.6

Number of hospitalization

3.1 ± 3.2

Rating scores

SAS

BARS

PANSS positive

PANSS negative

PANSS general psychopathology

PANSS total

CDSS

CGI-S

 

4.8 ± 3.6

0.7 ± 0.9

16.1 ± 1.6

27.4 ± 3.1

42.9 ± 3.0

86.4 ± 6.9

3.7 ± 1.8

5.0 ± 0.3

Abbreviations: CDSS, Calgary Depression Scale for Schizophrenia; CGI-S, Clinical Global Impression Scale; PANSS, Positive and Negative Syndrome Scale.

Results   Baseline

8 Weeks

SAS score 5.9 ± 3.2

1.1 ± 0.6

BARS global subscale 2.3 ± 0.3

2.0 ± 0.7

PANSS negative subscale 27.4 ± 3.1

24.3 ± 3.5

PANSS positive subscale 16.1 ± 1.6

13.7 ± 1.6

PANSS general psychopathological subscale 42.9 ± 3.0

41.6 ± 5.6

PANSS total score 86.4 ± 6.9

79.4 ± 10.1

CDSS

3.7 ± 1.8

5.0 ± 1.6
CGI-S 5.0 ± 0.3

4.9 ± 0.6

BARS global, objective, subjective, and distress subscales did not change significantly during the study.

Adverse Events

Depressed mood (2 subjects), suicidal ideation (2 subjects), drowsiness (1 subject), nausea (1 subject). Depressed mood occurred in subjects with akathisia, leading to deterioration of psychiatric symptoms and mood symptoms.

Study Author Conclusions

In conclusion, a low dose of pramipexole is efficacious in the treatment of antipsychotic-induced parkinsonism, but it did not show efficacy on akathisia. Our study also demonstrated that co-medication with pramipexole may be effective on psychiatric symptoms of schizophrenia, although the improvements are not very significant probably due to the low dose. The symptoms of mood are not improved after combining with the treatment of pramipexole. In general, the findings of this study suggest that the usage of the D 2/D3 partial agonist pramipexole could be beneficial in the treatment of neuroleptic-induced EPS, especially including drug-induced parkinsonism, and show a trend of improvement of schizophrenia symptoms. The results of this study need to be validated in a larger sample.

Critique

The study’s small sample size and open-label design limit generalizability, and the wide age range of participants may affect results. No patients received cariprazine, so the applicability of these findings to cariprazine-associated extrapyramidal symptoms or combination use is uncertain. Further studies with larger samples and controlled designs are needed to validate these findings.

 

References:
[1] [1] Weng JJ, Wang LH, Zhu H, et al. Efficacy of low-dose D2/D3 partial agonist pramipexole on neuroleptic-induced extrapyramidal symptoms and symptoms of schizophrenia: a stage-1 open-label pilot study. Neuropsychiatr Dis Treat. 2019;15:2195-2203. doi:10.2147/NDT.S205933