Emotion, Mood and Executive Function in Parkinson's Disease (PD)
- Registration Number
- NCT01385735
- Lead Sponsor
- St. Josef Hospital Bochum
- Brief Summary
The current study aims to assess the effect of an 8 week Azilect treatment (as adjunct therapy to levodopa) on affect perception and emotional expressiveness in a double-blind placebo-controlled study.
- Detailed Description
Parkinson's disease (PD) is associated with a range of cognitive impairments, most notably deficits of higher order cognitive control mechanisms referred to as "executive dysfunction". These problems have consistently been related to dysfunction of fronto-striatal circuitry (summary see Stocchi \& Brusa, 2000). Executive function impairments may already be present in early stages of PD (Uekermann et al., 2004) and their severity may be exacerbated by affective changes such as depression (Uekermann et al., 2003). In addition to cognitive problems, PD patients frequently suffer from mood changes, in particular apathy (Kirsch-Darrow et al., 2006) and from affect processing impairments, relating to both the ability to decode the affective state of other people on the basis of facial expressions or prosody and to the ability to adequately express the patients' own emotions (e.g. Breitenstein et al., 1998; Zgaljardic et al., 2003, Pell \& Leonard, 2005). The capacity for emotion perception was found to be linked to the severity of executive dysfunction; affective and cognitive changes are thus not independent, at least in patients with moderate PD (Breitenstein et al., 2001).
In a recent drug monitoring study by Lundbeck GmbH/TEVA Pharma GmbH based on a small group of PD patients (n=29), introduction of Azilect (Rasagiline) therapy was associated with a significant improvement of PD patients' emotional expressiveness (e.g. facial expression, gestures, voice intonation) over an 8 week observation period. Significant improvements were observed for self-ratings of emotional expressiveness as well as ratings by physicians and relatives. The lack of a placebo-control group, however, does not allow any firm conclusions with regard to the specificity of these effects.
Intact affect recognition and an adequate ability to express emotions are of critical importance for social interaction. The therapeutic efficacy of drug treatment on non-motor symptoms in PD has so far only rarely been addressed. The documentation of a beneficial effect of Azilect on emotional processing would be of great relevance for the quality of life of PD patients and greatly enhance their ability to participate in social life.
The addition of a placebo control group is critical for the assessment of the specificity of the expected beneficial effects of Azilect.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- idiopathic PD
- age range 30-75 yrs, HY I-III
- stable medication for at least 4 weeks prior to baseline
- Native speakers (German)
- signing of informed consent form
- clinically significant depression (BDI>13)
- freezing, pronounced fluctuations
- other neurological or psychiatric disorders
- dementia (MMSE<25)
- treatment with the MAO-B-inhibitor Selegiline, antidepressants
- any contraindication according to SmPC
- participation in another interventional study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 1 Tbl per day, 12 week (84 days) duration Rasagiline Rasagiline Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
- Primary Outcome Measures
Name Time Method Assess the effect of Azilect on mood, recognition of facial and vocal affect and emotional expressiveness 12 weeks * Discrimination Faces
* Discrimination Affect
* Affect Naming -Faces
* Discrimination linguistic prosody
* Discrimination affective prosody
* Affect naming -congruent and incongruent affective prosody Visual Analogue Scales of emotional expressiveness
* Rating by study physician and relative
* Self-rating by patient Assessment of executive function
* Working Memory (n-back task, digit backward)
* Verbal Fluency (Regensburger Wortflüssigkeitstest) Beck Depression Inventary (BDI) Apathie Evaluations-Skala (AES) Social Activity Scale - self assessment PDQ-39- self-assessment
- Secondary Outcome Measures
Name Time Method Effect on motor function in PD 12 weeks Unified Parkinson's Disease Rating Scale
Trial Locations
- Locations (1)
St. Josef Hospital
🇩🇪Bochum, Nordrhein-Westfalen, Germany