Pramipexole vs Escitalopram for Depression in HIV

Recruiting at 38 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

186 Participants Needed

Trial Summary

What is the purpose of this trial?

A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.

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.

What data supports the effectiveness of the drug Escitalopram for treating depression in HIV-positive patients?

Research shows that antidepressant medications, including Escitalopram, can be effective in treating depression among HIV-positive individuals, although the response can vary. A systematic review found that antidepressants had a moderate effect size, indicating some level of effectiveness, but the high placebo response suggests that results can be inconsistent. ^{1 2 3 4 5}

Is it safe to use Escitalopram or Pramipexole for depression in people with HIV?

Escitalopram, also known as Lexapro, is generally well-tolerated in people with HIV, though some may experience side effects like rash or nausea. It's important to consider potential interactions with HIV medications, and patient adherence to treatment is crucial for safety and effectiveness. ^{1 5 6 7 8}

How does the drug Pramipexole differ from other treatments for depression in HIV?

Pramipexole, typically used for Parkinson's disease, is being explored for depression in HIV due to its unique action on dopamine receptors, which is different from the serotonin-focused approach of standard antidepressants like escitalopram. ^{9 10 11 12 13}

Research Team

Karl Goodkin, MD, PhD

Principal Investigator

Neuropsychiatrist Consultant

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Escitalopram treatment of depression in human immunodeficiency virus/acquired immunodeficiency syndrome: a randomized, double-blind, placebo-controlled study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

The need for an integrated pharmacological response to the treatment of HIV/AIDS and depression. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Providers' attitudes towards treating depression and self-reported depression treatment practices in HIV outpatient care. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Citalopram treatment of major depressive disorder in Hispanic HIV and AIDS patients: a prospective study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetic drug-drug interaction study between raltegravir and citalopram. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Safety considerations in drug treatment of depression in HIV-positive patients: an updated review. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Drug treatment of depression in HIV-positive patients : safety considerations. [2022]

9. England 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. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on escitalopram in the management of major depressive disorder. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Escitalopram: a review of its use in the management of major depressive disorder. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Comparison of escitalopram versus citalopram for the treatment of major depressive disorder in a geriatric population. [2022]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Escitalopram: a review of its use in the management of major depressive disorder in adults. [2022]