Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
State University of New York - Upstate Medical University
This is an open-label (no placebo) study to see if a change from SSRI to Tiagabine may alleviate sexual dysfunction while maintaining subject in a non-anxious state. 30 Subjects ( at least 50% female) will currently be taking a single SSRI for at least 4 weeks and report at least a 50% drop in their anxiety severity as a result. They must also report a chronological emergence of sexual dysfunction ( decreased sex drive, arousal, lubrication, or onset of impotence, anorgasmia or delayed ejaculation) following the SSRI initiation. Subjects will complete consenting process and attend a screening visit where they will be given a MINI psychiatric diagnostic evaluation to confirm anxiety disorder, be given a Hamilton Anxiety and a Hospital Anxiety \& Depression Scale evaluation to delineate current anxiety level (secondary measure). They will also complete self rated sexual health scales such as the ASEX to assess sexual functioning (primary measure). Subjects will undergo a brief physical exam and bloodwork will be ordered if the patient has an underlying medical condition that warrants this type of medical clearance. The same would hold true if an EKG is needed. Neither SSRIs, nor tiagabine warrants blood monitoring or EKGs per the FDA. Assuming subject meets eligibility, they will start titrating upwards as tolerated on tiagabine and downwards on their SSRI. Titration with Tiagabine is flexible but typically starts at the night of Day 1: 4 mg/day (2mg qAm with breakfast and 2mq qHS before bedtime with a snack for five days). On day 6: 8mg/day (2mg with breakfast and 6mg before bedtime with a snack). Day 13: 12mg/day in split doses: (4mg am with breakfast and 8mg before bedtime with a snack). Two weeks after enrollment, all subjects will be called in order to check for any side effects to the study drug and to insure that each subject is titrating to the proper dose of study drug according to the study protocol. At the discretion of the investigator, dosing may be lowered to alleviate side effects. Vist 2 will occur at the end of week 4 when all SSRI is off and optimal tiagabine is in place. All scales except MINI will be completed. Vist 3 will occur at the end of week 8 and scales will be completed. Visit 4 will be the final visit at end of week 14, scales, PE and blood/EKG collected as warranted. The efficacy and safety of Tiagabine will be evaluated throughout the treatment period (see flow chart). At the end of the study, subjects may opt to continue tiagabine or be titrated back to their SSRI. Our team will also liaison with the subject's prescriber to ensure follow up and continuity of care after study exit.
Age
18–64
Sex
ALL
Healthy volunteers
Accepted
