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Can providing information about a generic medicine switch reduce side effect reporting?

Can providing information about a generic medicine switch reduce side effect reporting in patients taking lamotrigine for epilepsy and bipolar disorder?

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000654156
Enrollment
1500
Registered
2019-05-01
Start date
2019-05-20
Completion date
2019-10-31
Last updated
2025-01-06

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 purpose of this study is to investigate the effect of a text message notification and additional information on adjustment to a new medication brand. It is hypothesised that participants who receive additional nocebo information will report fewer side effects and have a greater perceived efficacy of the new medicine compared to a group who are just notified that their medicine brand is going to change. Participants will be allocated to one of two groups: either a group who are sent a text message that their medicine is changing, or a group sent this text as well as a brief video explaining the nocebo effect. Three weeks after the switch to the generic medicine, participants will be sent an online survey asking them about any side effects experienced and perceived efficacy of the new medicine.

Interventions

Participants are going to be switched to a generic medicine as a result of a funding change by PHARMAC, New Zealand. Participants will be sent one text message from their pharmacy, two weeks before they are scheduled to switch to a generic medicine. The text will contain one of two different messages (intervention or active control text), which participants have been randomly allocated to. The intervention text message will notify patients that their brand of lamotrigine has changed as well as p

Participants are going to be switched to a generic medicine as a result of a funding change by PHARMAC, New Zealand. Participants will be sent one text message from their pharmacy, two weeks before they are scheduled to switch to a generic medicine. The text will contain one of two different messages (intervention or active control text), which participants have been randomly allocated to. The intervention text message will notify patients that their brand of lamotrigine has changed as well as provide them with a 2 minute animated video, designed specifically for this study. This video discusses the nocebo effect and how this is relevant to the medicine switch by 1) becoming more aware of physical symptoms & 2) inappropriately misattributing them to the effects of a switch.

Sponsors

Professor Keith Petrie
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention

Eligibility

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

Inclusion criteria

Participants must be a patient of Green Cross Health - a New Zealand provider of primary care services. They must be taking either Lamictal or Arrow-lamotrigine before the medicine change. They must have a mobile phone number on file in the Green Cross database.

Exclusion criteria

Are taking Logem before the switch (i.e. will not be switching medicine brands) and do not have a mobile phone number in the Green Cross database

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026