This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and clinical outcome of chronic schizophrenic patients with residual, so-called 'positive' symptoms, as well as on cognition, motivation, subjective well-being of patients, negative symptoms, general psychopathological symptoms and safety/tolerability.
This exploratory study of 7 weeks was intended to be performed in 40 to 60 patients in up to 10 centers in Belgium. In a subset of patients, the 6-week treatment phase will be preceded by a single-dose cross-over phase with 1 week of wash-out. While the objective of the study, due to its exploratory design, is to assess any effect of the study medication on MRI or clinical outcome, the study medication is expected to improve the residual (remaining) positive symptom(s) of patients. In addition, genetic and pharmacokinetic testing may be performed to learn more about the disorder and its treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
7
15 mg PIP once daily per os on top of continued stable treatment with RIS or PAL
matching placebo sugar pill once daily per os on top of continued stable treatment with RIS or PAL
University Psychiatric Institute Sint-Jozef
Kortenberg, Belgium
Change from baseline in functional MRI tests
MRI = Magnetic Resonance Imaging Functional tests performed during MRI include the N-Back Test and the Monetary Incentive Delay (MID) Task Test
Time frame: 1 day, 2 weeks and 6 weeks after study treatment start
Change from baseline in residual PANSS item(s)
PANSS = Positive and Negative Syndrome Scale
Time frame: 2 weeks and 6 weeks after study treatment start
Change from baseline in SWN score and subitem scores
SWN = Subjective Well-being under Neuroleptics questionnaire
Time frame: 2 weeks and 6 weeks after study treatment start
Change from baseline in IMI-SR score and subitem scores
IMI-SR = Intrinsic Motivation Inventory for Schizophrenia Research (questionnaire)
Time frame: 2 weeks and 6 weeks after study treatment start
CGI-I score
CGI-I = Clinical Global Impression if Improvement
Time frame: 2 weeks and 6 weeks after study treatment start
Change from baseline in BARS total and subitem scores
BARS = Barnes Akathisia Rating Scale
Time frame: 6 weeks after study treatment start
Change from baseline in BACS score and subitem scores
BACS = Brief Assessment of Cognition Scale
Time frame: 1 day, 2 weeks and 6 weeks after study treatment start
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