Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction
Anxiety, Sexual Dysfunction
About this trial
This is an interventional treatment trial for Anxiety focused on measuring anxiety, sexual dysfunction, ssri
Eligibility Criteria
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: Written informed consent is obtained. The patient is English-speaking and 18 through 64 years of age inclusive. The patient meets the DSM-IV criteria for generalized anxiety disorder as determined by the MINI and psychiatric evaluation. The patient is currently responding to and taking a monotherapy SSRI (including venlafaxine) for ≥ 4 weeks and on a stable, adequate therapeutic for ≥ 4 weeks the patient reports clear sexual side effects post dating the SSRI start The patient has a total score of at less than 18 on the HAM-A scale (i) The patient is in good health as determined by a medical and psychiatric history, medical examination, (j) Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen). Women must be given a pregnancy test (ßHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative. (k) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol. Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: Other current mental illness/disorder The patient is a significant risk of suicide (d) The patient has a history of greater than one previous depressive episode or has not been in remission >1 year (e) The patient cannot take sildenafil or any other sexually enhancing agent (f) The patient has any serious, unresolved or unstable medical and/or psychiatric condition (treated or untreated). (g) The patient has previously participated in any clinical study with GABITRIL or treated with GABITRIL. (h) The patient is a pregnant or lactating woman (women becoming pregnant during the study will be withdrawn from the study). (l) The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial. (m) The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) or have an explainable medical condition causing sexual dysfunction (n) The patient has had alcohol or sedative dependence within last one year or any other illegal substance abuse/dependence in last 3 months including heavy caffeine, nicotine use contributing to anxiety state (o) The patient is unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator. (p) The patient has a clinically significant deviation from normal in the physical examination. -
Sites / Locations
- Psychiatry Dept. SUNY Upstate Medical University