An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
This study is ongoing, but not recruiting participants.
Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01716221
First received: October 25, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.
| Condition | Intervention | Phase |
|---|---|---|
|
Friedreich Ataxia |
Drug: bupropion & Citalopram Drug: Bupropion & Placebo Drug: Placebo & Citalopram Drug: Placebo & Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
Resource links provided by NLM:
Genetics Home Reference related topics:
ataxia neuropathy spectrum
childhood myocerebrohepatopathy spectrum
deoxyguanosine kinase deficiency
Friedreich ataxia
infantile-onset spinocerebellar ataxia
Marinesco-Sjögren syndrome
mitochondrial neurogastrointestinal encephalopathy disease
myoclonic epilepsy myopathy sensory ataxia
spinocerebellar ataxia type 1
spinocerebellar ataxia type 2
spinocerebellar ataxia type 3
spinocerebellar ataxia type 6
MedlinePlus related topics:
Friedreich's Ataxia
Drug Information available for:
Bupropion hydrochloride
Bupropion
Citalopram hydrobromide
Citalopram
Escitalopram oxalate
U.S. FDA Resources
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- International Cooperative Ataxia Rating Scale (ICARS) [ Time Frame: Change from Baseline at 5, 10, 15, and 20 weeks ] [ Designated as safety issue: No ]
- Friedreich Ataxia Rating Scale (FARS) [ Time Frame: Change from Baseline at 5, 10, 15, and 20 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Comparison of FARS and ICARS [ Time Frame: Baseline and weeks 5, 10, 15, and 20 scales ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Hamilton Depression Rating Scale [ Time Frame: Baseline and at 5, 10, 15, and 20 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 1 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bupropion & Citalopram
100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day
|
Drug: bupropion & Citalopram |
|
Active Comparator: Bupropion & Placebo
100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day
|
Drug: Bupropion & Placebo |
|
Active Comparator: Placebo & Citalopram
Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day
|
Drug: Placebo & Citalopram |
|
Placebo Comparator: Placebo & Placebo
Placebo & Placebo taken orally one time per day
|
Drug: Placebo & Placebo |
Eligibility| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: N/A -
Exclusion Criteria: N/A
-
Contacts and Locations More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01716221 History of Changes |
| Other Study ID Numbers: | 11-1141 |
| Study First Received: | October 25, 2012 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ataxia Friedreich Ataxia Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Spinocerebellar Degenerations Cerebellar Diseases Brain Diseases Central Nervous System Diseases Spinal Cord Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mitochondrial Diseases |
Metabolic Diseases Citalopram Bupropion Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents |
ClinicalTrials.gov processed this record on June 17, 2013