TY - JOUR
T1 - Add-On Pramipexole for the Treatment of Schizophrenia and Schizoaffective Disorder
T2 - A Randomized Controlled Trial
AU - Levi, Linda
AU - Zamora, Daisy
AU - Nastas, Igor
AU - Gonen, Ilan
AU - Radu, Paull
AU - Matei, Valentin
AU - Ciobanu, Adela M.
AU - Nacu, Anatol
AU - Boronin, Larisa
AU - Karakrah, Lusian
AU - Davidson, Michael
AU - Davis, John M.
AU - Weiser, Mark
N1 - Publisher Copyright:
© 2022 Physicians Postgraduate Press, Inc.
PY - 2022/9
Y1 - 2022/9
N2 - Objective: Several small clinical trials have reported that the dopamine agonist pramipexole was beneficial in treating patients with schizophrenia. A confirmatory trial was conducted to test this hypothesis. Methods: This 16-week, multicenter, double-blind, randomized, placebo-controlled study included 200 subjects meeting DSM-IV-TR criteria for schizophrenia or schizoaffective disorder. Patients were randomized to receive either pramipexole (0.75 mg twice daily, n = 100) or placebo (n = 100) as an add-on to their regular antipsychotic treatment. The primary outcome measure was the total score on the Positive and Negative Syndrome Scale (PANSS); secondary outcome measures included PANSS subscale and cognitive functioning scores. Recruitment was performed in 30 sites in Romania and 1 site in the Republic of Moldova between January and June 2011. Results: Analysis of covariance models showed no significant difference between pramipexole and placebo for total PANSS (P> .99) and PANSS positive (P> .99), negative (P= .73), and general psychopathology (P= .99) subscale scores. Changes in Clinical Global Impressions–Severity of Illness scale and Brief Assessment of Cognition in Schizophrenia scores showed no significant difference between pramipexole and placebo. Conclusions: The results of this large randomized controlled trial indicated that pramipexole was not efficacious as an add-on to antipsychotic medications for schizophrenia.
AB - Objective: Several small clinical trials have reported that the dopamine agonist pramipexole was beneficial in treating patients with schizophrenia. A confirmatory trial was conducted to test this hypothesis. Methods: This 16-week, multicenter, double-blind, randomized, placebo-controlled study included 200 subjects meeting DSM-IV-TR criteria for schizophrenia or schizoaffective disorder. Patients were randomized to receive either pramipexole (0.75 mg twice daily, n = 100) or placebo (n = 100) as an add-on to their regular antipsychotic treatment. The primary outcome measure was the total score on the Positive and Negative Syndrome Scale (PANSS); secondary outcome measures included PANSS subscale and cognitive functioning scores. Recruitment was performed in 30 sites in Romania and 1 site in the Republic of Moldova between January and June 2011. Results: Analysis of covariance models showed no significant difference between pramipexole and placebo for total PANSS (P> .99) and PANSS positive (P> .99), negative (P= .73), and general psychopathology (P= .99) subscale scores. Changes in Clinical Global Impressions–Severity of Illness scale and Brief Assessment of Cognition in Schizophrenia scores showed no significant difference between pramipexole and placebo. Conclusions: The results of this large randomized controlled trial indicated that pramipexole was not efficacious as an add-on to antipsychotic medications for schizophrenia.
UR - http://www.scopus.com/inward/record.url?scp=85135500068&partnerID=8YFLogxK
U2 - 10.4088/JCP.21M14233
DO - 10.4088/JCP.21M14233
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C2 - 35921506
AN - SCOPUS:85135500068
SN - 0160-6689
VL - 83
JO - Journal of Clinical Psychiatry
JF - Journal of Clinical Psychiatry
IS - 5
M1 - 21m14233
ER -