Bipolar Bozukluk ve Alkol Kullanım Bozukluklarında Ondansetron

Sade dilde özet

Bu çalışma, hem bipolar bozukluk (bipolar disorder) türünde bir duygudurum bozukluğu hem de alkol kullanım bozukluğu (alcohol use disorder) olan yetişkinlerde Ondansetron adlı ilacı plaseboyla karşılaştırarak değerlendirmektedir. Çalışmaya, duygudurum düzenleyici tedavisi stabil olan ve yakın zamanda alkol kullanımı olan 18-70 yaş arası ayaktan takip edilen hastalar katılabilmiştir. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

University of Texas Southwestern Medical Center

Müdahale

Ondansetron, Placebo

Başlangıç

01.02.2014

Tahmini bitiş

01.05.2018

Ülkeler

United States

İlgili genler

Merkezler

• Dallas, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Outpatient men and women age 18-70 years old with bipolar I, II, or Not Otherwise Specified (NOS) disorders, schizoaffective disorder (bipolar type), cyclothymic disorder, or major depressive disorder with mixed features
* Current diagnosis of alcohol use disorder (DSM V terminology) with onset ≤ age 25
* Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to intake
* IF diagnosis of Bipolar I, II, or NOS Disorder: Current mood stabilizer therapy (lithium, anticonvulsant, atypical antipsychotic) with stable dose for at least 14 days prior to randomization
* IF diagnosis of Schizoaffective disorder (bipolar type): Current atypical antipsychotic therapy with stable dose for at least 14 days prior to randomization
* IF diagnosis of Major Depressive Disorder with mixed features: Current antidepressant therapy with stable dose for at least 14 days prior to randomization

Exclusion Criteria:

* Baseline Young Mania Rating Scale (YMRS) or Hamilton Rating Scale for Depression (HAMD) scores ≥ 35 to exclude those with very severe mood symptoms
* Evidence of clinically significant alcohol withdrawal symptoms defined as a CIWA-Ar (Clinical Institute Withdrawal Assessment of Alcohol Use-Revised) score of ≥ 10
* Therapy in past 14 days with naltrexone, acamprosate, disulfiram, or topiramate
* Vulnerable populations (e.g. pregnant, breastfeeding, incarcerated, cognitively impaired (e.g. dementia, mentally challenged))
* High risk of suicide defined as \> 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
* Intensive outpatient treatment (defined as ≥ 3 visits each week) for substance abuse (AA, NA meetings, or less intensive counseling at baseline will be allowed)
* Severe or life-threatening medical condition (e.g., hepatic cirrhosis) or laboratory or physical examination findings consistent with serious medical illness (e.g., dangerously abnormal electrolytes)
* AST (aspartate aminotransferase ) or ALT (alanine transaminase) \> 3 times the upper limit of normal
* History of severe side effects or allergic reaction with prior ondansetron therapy (e.g. for vomiting) or use of medications with significant drug-drug interactions with ondansetron (phenytoin, carbamazepine, and rifampicin, apomorphine, tramadol)