Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13)
研究概览
简要总结
This is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (PGD). Participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older.
- •Lives within a reasonable distance from NYPH for convenient clinic visits.
- •Can speak, read, and write English proficiently.
- •Meet diagnostic criteria for PGD based on the DSM guidelines
- •If a female patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while she is taking the study drug. Female patients who are planning to use oral hormonal contraception during this time must have initiated it at least 2 months prior to the baseline visit.
- •If a male patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while he is taking the study drug.
排除标准
- •Having recently started taking/prescribed medications for any psychiatric illness (e.g. SSRIs for MDD) within the past 3 months; participants who have been taking this medication for longer than 3 months can be included.
- •Having recently started psychotherapy for any psychiatric illness within the past 3 months; participants who have been receiving psychotherapy for longer than 3 months can be included.
- •Prior history of recently active (e.g. within the past 3 months) opioid dependence.
- •Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including opioid antagonists for alcohol or opioid dependence, all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide).
- •Possible future use of opioids during the study (e.g. for surgery).
- •Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril), or any other clinically relevant medication that has potential to cause liver injury with concurrent use of naltrexone.
- •Currently pregnant, lactating, or planning to become pregnant during the study.
- •Active hepatitis or liver disease.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal on initial laboratory examination.
- •Screen positive for active suicidal thoughts or behaviors.
研究组 & 干预措施
Placebo
24 randomized patients will take placebo daily for 8 weeks.
干预措施: Placebo (Drug)
Naltrexone
24 randomized patients will take naltrexone daily for 8 weeks
干预措施: Naltrexone HCl 50 MG Oral Tablet (Drug)
结局指标
主要结局
Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13)
时间窗: Baseline and 8 Weeks
Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.
Change in Number of Participants With Prolonged Grief Disorder as Assessed by Structured Clinical Interview for PGD (SCIP)
时间窗: Every 4 weeks for 8 weeks
Eligibility for the study and change in symptom severity will be measured by SCIP. This structured clinical interview is adapted to the DSM-5-TR criteria for PGD. Interviewers will be trained to standard which will be a κ \> 0.8 agreement between trainee and trainer.
Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13
时间窗: Baseline and 12 weeks
Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies. Minimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of ≥30 is the threshold for "syndromal" level PGD. Prolonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.
次要结局
- Change in Strength of Subjectively Perceived Closeness of a Social Relationship as Measured by the Inclusion of the Other in the Self (IOS) Scale(Every 4 weeks for 12 weeks)