Wellness Study

Efficacy of low dose escitalopram v's placebo in the amelioration of anxiety and fatigue in patients who are unwell or suffer chronic illness

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000398303

Enrollment

Registered

2008-08-08

Start date

2007-07-20

Completion date

2011-06-13

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 Wellness Study will evaluate 6 weeks of very low dose Escitalopram (50 micrograms) compared to placebo on fatigue, anxiety and depression in chronic medical illness. Following a 3 week baseline run in-phase, participants will be randomised 'double blind' to the active or placebo treatment, incorporating 4 study centre visits in all. Associated clinical benefits may include improvements in sleep, weight reduction, heart rate and blood pressure. Although serotonin re-uptake inhibitors have never previously been studied at such a low dose, clinical results to date appear encouraging.

Interventions

0.05mg escitalopram oxalate in a lactose base in an opaque capsule. 1 capsule taken daily via oral route for a period of 6 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Chronic illness - patients who are generally unwell for an extended period.

Exclusion criteria

Patients with Malignancy or taking any prescribed antidepressant and/or pyschotrophic medication will be excluded from the trial.

Outcome results