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The goals of this pilot study are to gather data about the safety and clinical effect of low-dose buprenorphine in older adults with treatment resistant depression.
We will recruit 20 participants (two per month) from the ongoing study: "Incomplete Response in Late-Life Depression: Getting to Remission" (MH083660; PI: Reynolds) who did not meet response criteria defined as at least two consecutive MADRS < 10 and at least a 2 point drop in the MADRS from randomization. These subjects are all > 60 years old with MMSE scores > 24 who were exposed to 12-16 weeks of venlafaxine (up to 300 mg/day) + 12 week augmentation with either aripiprazole (dosed up to 15 mg/day) or placebo (ARI/PBO).
Overview of intervention: To guide future placebo-controlled work, at this preliminary stage of research we will collect data about both buprenorphine (BUP) 1) augmentation pharmacotherapy, and 2) monotherapy. Although all subjects did not meet response according to the parent (MH083660; PI: Reynolds) protocol, for this project we define response status at entry as: 1) incomplete response (MADRS 10-14) or 2) non-response (MADRS >/= 15).
For incomplete responders, we will augment venlafaxine with buprenorphine. For non-responders, we will discontinue the venlafaxine over 1-3 weeks (according to subject comfort with discontinuing the medication) before starting buprenorphine. The venlafaxine dose will remain stable if continued for the partial responders. The aripiprazole/placebo (ARI/PBO) (to which subjects had been randomized during the last 12 weeks of the parent study) will be discontinued over 1-2 weeks and all subjects will be ARI/PBO-free for 1 week before exposure to buprenorphine (to minimize changes in dopamine receptor density across subjects exposed to either ARI or PBO).
BUP 0.2 mg will be used for the first week. The first dose will be administered at the clinic under the supervision of the PI. Because peak plasma levels occur 60 minutes after ingestion, subjects will be re-assessed after 1 hour for safety. Participants will be seen weekly for eight weeks to assess progress and monitor intervention-emergent side effects. Dosing increases will be guided by antidepressant response (e.g., continued MADRS scores > 10 will trigger an increase dose of BUP) and our protocolized use of the Frequency, Intensity, and Burden of Side Effect Rating (FIBSER) Scale score. For example, a score of 5 to 7 on the FIBSER will trigger additional assessment of side effects and require justification for increasing the dose, while a score of > 7 will signal no increase in dose, although specific side effects should be reviewed in detail before a final determination, including review if the UKU Side Effects Rating Scale.
We will increase the dose by 0.2 mg/week up to 1.6 mg/day based on MADRS and FIBSER scores. Every time the dose is increased, the first ingestion of the higher dose will be monitored in the clinic as described above.
Subjects will participate in the project at the Late-Life Depression Clinic on the 7th Floor of Bellefield Tower. Subjects will complete paper and pencil and clinician-administered psychiatric assessments before receiving the first dose of buprenorphine and at all subsequent visits. After the first ingestion and all subsequent first ingestions of higher doses of BUP, subjects will remain in the clinic for 60 minutes after ingestion and be re-assessed for the emergence of side effects and have vital signs re-checked. The duration of the first visit will be approximately 2.5 hours. If subsequent visits require observed ingestion of buprenorphine, they will last about 1.75 hours. If subsequent visits do not require observed ingestion of buprenorphine, these visits will last 30-45 minutes.
Prior to the first ingestion, the first ingestion of subsequent higher doses, and at study end, subjects will complete a 15 minute battery of computerized neuropsychological tests assessing reaction time and attention. These tests will be repeated 60 minutes after the ingestion. Prior to the first ingestion and after discontinuation of the buprenorphine, memory will be assessed with the Hopkins Verbal Learning Test (HVLT). The HVLT takes about 10 minutes to complete.
The discontinuation phase will occur during weeks 9-12. To minimize the risk of withdrawal symptoms, we will discontinue the buprenorphine slowly by reducing the dose to 0.4 mg/day for 7 days, then 0.2 mg/day every other day for 7 days, and then stop the buprenorphine. We will see subjects weekly over these four weeks.
The final visit will occur at week 16. This will be a telephone check in of mood and functioning. This call will take about 15-20 minutes.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Western Psychiatric Institute and Clinica, University of Pittsburgh School of Medicine
Not yet recruiting
University of Pittsburgh
Published on BioPortfolio: 2014-08-27T03:15:48-0400
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