Sertraline Heart Study

Efficacy of low dose Sertraline v's placebo in the amelioration of anxiety in heart disease.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000329561

Acronym

Nil

Enrollment

Registered

2006-08-03

Start date

2006-01-01

Completion date

2007-07-01

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 low dose Sertraline Heart Study is a 3 month study evaluating improvements in energy, stress and well-being with very low dose Sertraline in patients with stable heart disease. Associated benefits may include improved sleep, weight and blood pressure. Being a serotonin reuptake inhibitor, we are also interested to monitor improvements in anxiety and mood, which have never been evaluated at this very low dose before. Half of the participants will receive 'blank' or placebo capsules. There are 4 visits to the study centre over the 3 months, at which symptoms will be monitored. Blood tests are undertaken initially and at 6 weeks. Subjects, Research Assistant and Medical Director are all blinded.

Interventions

Intervention 5mg Sertraline in a lactose base in an identical capsule. 1 d for 12/52 via oral route. The complete period of the trial is ~3 months.

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

Abnormal echocardiogram with history of any cardiac symptoms.

Exclusion criteria

Malignancy & Psychotrophics.

Outcome results