Pramipexole vs Escitalopram for Depression in HIV

Not yet recruiting at 42 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: ART regimen

Must not be taking: Antiepileptics, Immunosuppressives

Disqualifiers: Severe MDD, Psychotic disorders, Alcohol use, CAD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments, pramipexole and escitalopram (an antidepressant), to determine which is more effective for treating depression in people with HIV. Researchers aim to assess the safety and effectiveness of these treatments, particularly for those with mild memory and thinking problems. The trial suits individuals with HIV who have maintained a steady HIV treatment plan and have been diagnosed with major depression but are not currently using antidepressants. Participants will receive close monitoring for side effects and changes in depression symptoms throughout the study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial requires that participants stop taking any antidepressants at least 4 weeks before joining, except for fluoxetine, which must be stopped at least 8 weeks prior. Additionally, you must not change your current HIV treatment while in the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pramipexole is usually well-tolerated, though some studies mention side effects like nausea and dizziness. Patients with Parkinson's disease using pramipexole have responded better than those taking a placebo, suggesting it could be a promising option for depression.

Studies indicate that escitalopram is safe for people with HIV. This antidepressant is commonly used and is known for having manageable side effects. It has been effective in treating depression in HIV patients.

Both treatments are being tested for their effectiveness in treating depression in people with HIV. Based on past research, both pramipexole and escitalopram are considered safe, but individual reactions can vary. Researchers will closely monitor participants during the trial to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new approaches to managing depression in individuals with HIV. Pramipexole ER is unique because it targets the dopamine system, potentially offering benefits for mood and motivation, which is different from most standard antidepressants like SSRIs that focus on serotonin. On the other hand, Escitalopram is a well-known SSRI that is being investigated for its effectiveness specifically in the context of HIV-related depression. By exploring these two different mechanisms, researchers hope to find more effective ways to alleviate depressive symptoms in this specific population.

What evidence suggests that this trial's treatments could be effective for depression in HIV?

This trial will compare Pramipexole ER and Escitalopram for treating depression in individuals with HIV. Research has shown that Pramipexole can reduce depression symptoms in people with Parkinson's disease, suggesting potential benefits for depression in other conditions. Some studies indicate that Pramipexole may be effective for depression unresponsive to other treatments.

For Escitalopram, studies demonstrate it can significantly reduce depression symptoms, helping many feel better. However, in people with HIV, one study found it wasn't more effective than a placebo, possibly due to a strong placebo effect. Both treatments have shown promise, but results can vary depending on the condition and the individual. Participants in this trial will receive either Pramipexole ER or Escitalopram to evaluate their effectiveness in this specific population. ^{2 3 6 7 8}

Who Is on the Research Team?

Karl Goodkin, MD, PhD

Principal Investigator

Neuropsychiatrist Consultant

Are You a Good Fit for This Trial?

This trial is for individuals with HIV who are experiencing major depressive disorder (MDD) and may also have mild neurocognitive disorder (MND). Specific eligibility criteria details were not provided, so interested participants should inquire further to determine if they qualify.

Inclusion Criteria

Laboratory values obtained within 30 days prior to study entry that meet protocol criteria as determined by the site investigator of record

Study candidates of child-bearing potential must have a negative serum or urine pregnancy test performed at screening and within 2 days prior to study entry

I have been on my current HIV treatment for at least 90 days without a break longer than a week.

Exclusion Criteria

I have an active hepatitis C infection that hasn't been treated.

Severe, active alcohol or substance use disorder by DSM-5-TR criteria in the 6 months prior to study entry

Active alcohol or substance use judged by the investigator to interfere with the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pramipexole ER or escitalopram and are assessed for safety, efficacy, and dose adjustments

24 weeks

Comprehensive and brief intercurrent visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Sub-study

Evaluation of treatment impact on cerebrospinal fluid (CSF) profile in a subset of participants

What Are the Treatments Tested in This Trial?

Interventions

• Escitalopram
• Pramipexole ER

Trial Overview

The study compares the safety and effectiveness of two medications: Pramipexole ER, a drug often used for Parkinson's disease, against Escitalopram, a common antidepressant. It aims to see which is better for treating depression in people with HIV.

How Is the Trial Designed?

Group I: Arm 2: Escitalopram Experimental Treatment 1 Intervention

Group II: Arm 1: Pramipexole ER Experimental Treatment 1 Intervention

Escitalopram is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lexapro for:

• Major depressive disorder
• Generalized anxiety disorder

Approved in European Union as Cipralex for:

• Major depressive episodes
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder with or without agoraphobia
• Obsessive-compulsive disorder

Approved in Canada as Cipralex for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Cipla Ltd.

Industry Sponsor

Trials

10

Recruited

28,800+

Published Research Related to This Trial

Escitalopram is a highly effective and well-tolerated treatment for moderate-to-severe major depressive disorder (MDD), showing consistent superiority over citalopram based on pooled clinical trial data.

Preliminary studies indicate that escitalopram's efficacy is comparable to other SSRIs and venlafaxine, with potential cost-effectiveness benefits, making it a strong first-line treatment option for MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on escitalopram in the management of major depressive disorder. Murdoch, D., Keam, SJ.[2022]

In a 24-week study involving 357 patients with moderate to severe major depressive disorder, escitalopram was found to be at least as effective as citalopram, with statistically significant superiority in improving overall severity of depression by Week 24.

Both medications were safe and well tolerated, but escitalopram had fewer patient withdrawals compared to citalopram, highlighting its potential for better long-term adherence in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, 24-week study of escitalopram (10 mg/day) versus citalopram (20 mg/day) in primary care patients with major depressive disorder. Colonna, L., Andersen, HF., Reines, EH.[2022]

In a study of 691 geriatric patients, those treated with escitalopram showed better treatment persistence and were less likely to switch medications compared to those on citalopram, indicating escitalopram may be a more reliable option for older adults with major depressive disorder.

Patients on escitalopram experienced significantly fewer hospitalizations and lower total healthcare costs, primarily due to reduced hospitalization rates, suggesting that escitalopram not only helps manage depression effectively but also reduces overall healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of escitalopram versus citalopram for the treatment of major depressive disorder in a geriatric population. Wu, E., Greenberg, PE., Yang, E., et al.[2022]

Antidepressant medications have been found to be effective in treating depression among HIV-positive individuals, with a pooled effect size of 0.57 based on a systematic review of 7 studies involving 494 subjects.

However, the studies showed significant variability in results, largely influenced by placebo responses, and highlighted a concerning lack of representation of women and minorities, suggesting that future research should focus on these underrepresented groups to improve generalizability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of antidepressant medication among HIV-positive individuals with depression: a systematic review and meta-analysis. Himelhoch, S., Medoff, DR.[2022]

Patients with HIV should be routinely screened for major depression, as accurate diagnosis is crucial to avoid harmful exposure to inappropriate psychotropic medications.

Antidepressants used to treat major depression in HIV-infected patients are similar to those used in the general population, and while no specific antidepressant is superior, patient adherence is key, influenced by the side effects of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment of depression in HIV-positive patients : safety considerations. Pieper, AA., Treisman, GJ.[2022]

Citations

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sciencedirect.com

sciencedirect.com/science/article/pii/S2667174325001818

A Placebo-Controlled Randomized Trial of the Effects ...

Participants showed a significant reduction in depressive symptoms from pre-treatment to post-treatment, with a final HAM-D17 score of 8.0 (7.6) ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4669218/

The Effect of Antidepressant Treatment on HIV and ...

In the largest trial of its kind among HIV-infected adults, MBC did not improve HIV outcomes, possibly because of high baseline adherence, but achieved ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7390792/

Double blind, randomised trial to compare efficacy of ...

The study outcome was better in patients treated with escitalopram. The mean change in depression score from baseline to the end of the study was greater in ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0889159118301831

Effectiveness of depression interventions for people living ...

This meta-analytic review evaluated the effectiveness of depression interventions on the psychological and immunological outcomes of people living with HIV ...

5.

journals.lww.com

journals.lww.com/jonmd/fulltext/2014/02000/escitalopram_treatment_of_depression_in_human.9.aspx?generateEpub=Article%7Cjonmd:2014:02000:00009%7C10.1097/nmd.0000000000000082%7C

A Randomized, Double-Blind, Placebo-Controlled Study

This study found no statistically significant advantage for escitalopram over placebo in the treatment of depression in HIV. A high placebo response (59 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4397684/

The impact of HIV/AIDS on compliance with antidepressant ...

This study found that patients diagnosed with both HIV/AIDS and MDD (74.43. ± 32.03, 95% Cl: 71.51-77.34) have a statistical significantly lower compliance with ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00887679

Study Details | NCT00887679 | Treatment Effects of ...

Escitalopram has been used in the treatment of GAD in the general population. It has been shown to be safe in HIV-patients with a tolerable side-effect profile.

8.

aseanjournalofpsychiatry.org

aseanjournalofpsychiatry.org/articles/escitalopram-and-mirtazapine-for-the-treatment-of-depression-in-hiv-patients-a-randomized-controlled-open-label-trial.pdf

A RANDOMIZED CONTROLLED OPEN LABEL TRIAL

In this trial we compare the the safety and efficacy of mirtazapine and escitalopram in HIV patients for the treatment of depression.