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Low Dose Atomoxetine in Cardiovascular Disease: A Pilot Study

Effect of low dose Atomoxetine on stress/anxiety levels and cardiovascular risk in patients with hypertension, hypercholesterolemia, diabetes or other cardiovascular disease.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000376549
Enrollment
2
Registered
2015-04-23
Start date
2015-07-14
Completion date
2015-08-19
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the pilot study is to establish whether low dose Atomoxetine can be clinically effective in reducing stress/anxiety, have a favourable effects on cardiovascular risk, by not increasing and possibly reducing weight, along with blood pressure, blood cholesterol and glucose. The plan is to recruit 20 clinically stable patients for a 4 week "run-in" to establish a clear baseline, then prescribe Atomoxetine for 8 weeks. In consenting patients a further 6 weeks of double blind placebo v active will follow. All participants will be evaluated with a full history and physical examination.

Interventions

Oral capsule of Atomoxetine Slow Release 3mg taken once daily for 8 weeks. Compliance will be monitored by drug capsule return. Followed by 6 weeks of the same schedule during which time the field will be randomised with a placebo.

Sponsors

Professor Simon Dimmitt
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

currently prescribed medication to treat hypertension, hypercholesterolaemia or diabetes; or have previously suffered an arterial clinical event such as angina, acute myocardial infarction, transient ischemic event, stroke or retinal infarct/haemorrhage; and have a body mass index of greater than 25; and elevated DASS sub scale score (stress > 4, anxiety > 4 or depression > 4)

Exclusion criteria

unstable physical illness, clinical and/or questionnaire evidence of major psychiatric disorder and/or patients currently on psychotropic medication, a DASS score > 21, patients with atrial fibrillation or blood pressure > 170/110

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026