Treatment of hot flashes with low-dose risperidone
| ISRCTN | ISRCTN05964399 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05964399 |
| Protocol serial number | KTCT-P2a |
| Sponsor | Kuang-Tien General Hospital (Taiwan) |
| Funder | Kuang-Tien General Hospital (Taiwan) - investigator led study |
- Submission date
- 23/06/2010
- Registration date
- 08/07/2010
- Last edited
- 08/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hung-Ming Wu
Scientific
Scientific
135 Nanxiao St.
Changhua City
Changhua
500
Taiwan
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot prospective non-randomised uncontrolled trial |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Treatment of hot flashes with low-dose risperidone: An uncontrolled pilot study |
| Study objectives | By chance, risperidone was reported to have an effect on remission of hot flashes. We postulate that risperidone could sereve as a potential drug to treat hot flashes. |
| Ethics approval(s) | The Research Ethics Committee of Kuang-Tein General Hospital approved on the 20th of March 2005 (ref: KTCTP2a) |
| Health condition(s) or problem(s) studied | Hot flashes |
| Intervention | Patients complete hot flash diaries regarding the frequency and severity of hot flashes everyday in a one-week baseline period, in the 3-month risperidone treatment period, and during the first two weeks after total risperidone withdrawal. |
| Intervention type | Other |
| Primary outcome measure(s) |
The efficacy of risperidone for hot flashes is assessed by the average number of hot flashes per day, and the average daily hot-flash score (frequency × severity) |
| Key secondary outcome measure(s) |
None |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 6 |
| Key inclusion criteria | Menopausal (perimenopausal or postmenopausal) women with at least a moderate severity (i.e., ≥ 2 on a 04 scale) of hot flashes |
| Key exclusion criteria | 1. Menopausal women who take antipsychotic drug or/and antidepressants 2. Menopausal women who have breast cancer |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
135 Nanxiao St.
Changhua
500
Taiwan
500
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
