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Apathy Cure Through Bupropion in Huntington's Disease | Clinical Trials | Clareo Health

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Apathy Cure Through Bupropion in Huntington's Disease

A Randomized, Double-blind, Placebo-controlled Prospective Crossover Trial Investigating the Efficacy and Safety of the Treatment With Bupropion in Patients With Apathy in Huntington's Disease

NCT01914965•Charite University, Berlin, Germany

View on ClinicalTrials.gov

Summary

The influence of bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-I, where I \[informant\] is a friend or family member familiar with the daily activities of the subject) in patients with HD after ten (10) weeks of treatment.

Detailed Description

The safety and tolerability of Bupropion in HD. The influence of Bupropion compared to placebo on the: * change of apathy as quantified by the AES-C (clinician) or the AES-S (self), * change of motor symptoms (UHDRS) and quantitative grip force motor assessment, * change of cognitive symptoms (UHDRS and MMSE), * change of psychiatric symptoms (UHDRS, HADS), * change of activities of daily living (UHDRS), * change of the NPI caregivers' distress score (NPI-D), * change of ventral striatal and ventromedial prefrontal activation in response to a reward paradigm as quantified by fMRI.

Eligibility

Age

25 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Verified HD mutation carriers aged 25 to 75 years (inclusive) at first dosing
•2. Apathetic as diagnosed by SCIA-D criteria
•3. Stable concomitant medication (no change of medication during last six weeks prior to inclusion)
•4. Written informed consent by prospective study participant before conduct of any trial-related procedure. Participant must be able to make an informed decision of whether or not to participate in the study
•5. Patient has a caregiver (family member or friend), who is living in a close relationship with the patient and is willing to give written informed consent (caregiver) before performance of any trial-related procedure

Exclusion Criteria

•1. Pregnant or nursing women
•2. Active suicidality based on the answer "yes" in questions 4 and 5 of the Columbia-Suicide Severity Rating Scale (baseline version)
•3. Woman of childbearing potential, not using highly effective methods of contraception defined as methods with a Pearl Index \< 1 such as oral, topical or injected contraception, IUD, contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral tubal ligation) or not at least one year post-menopausal
•4. Male not using an acceptable barrier method for contraception and donating sperm from screening up to three months following treatment
•5. Presence or history of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus)
•6. Presence or history of seizures or diagnosed epilepsy or history of severe head trauma (contusion) or CNS tumor
•7. Clinical significant renal (calculated creatine clearance \< 60 ml/min) or hepatic dysfunction
•8. Clinical significant depression defined by the NPI depression score (score ≥4 points) at screening
•9. Schizophreniform psychosis within the last 6 months prior to first dose
•10. History of anorexia or bulimia
+11 more criteria

Locations (2)

Neurologische Klinik der Ruhr-Universität Bochum

Bochum, Germany

Universitätsklinikum Ulm, Klinik für Neurologie

Ulm, Germany

Key Dates

Start Date

June 1, 2012

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

September 9, 2014

Enrollment

ACTUAL participants

Conditions

ApathyHuntington's Disease

Interventions

Bupropion

DRUG

Placebo

DRUG

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

NCT02855476

Huntington's Disease

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RECRUITINGNA

A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Apathy Cure Through Bupropion in Huntington's Disease

Inclusion Criteria

Exclusion Criteria

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults

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Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease