SSRI Therapy for Depression (CAN-D Trial)

N/A

Recruiting

Led By Owen Wolkowitz, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of child-bearing capacity must be non-pregnant (confirmed by urine pregnancy test) and using effective non-hormonal birth control (e.g. abstinence, condoms, IUD)

Age 21-60 and able to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will help us understand if there are natural differences in blood levels of certain compounds and genetic markers between patients with depression and healthy adults, and if any such differences relate to memory performance, mood, and neurobiology.

Who is the study for?

This study is for adults aged 21-60 with a current diagnosis of Major Depressive Disorder, experiencing a depressive episode lasting over 6 weeks. Participants must be in good health, not using drugs or certain medications, and women must use non-hormonal birth control. People with neurological disorders, recent concussions, substance abuse issues, or those who are needle-phobic cannot join.

What is being tested?

The trial examines how blood compounds and genetic markers related to depression may change after eight weeks of treatment with an SSRI (a type of antidepressant). It also looks at the impact on memory performance, mood changes, and gut microbiome compared to healthy individuals without depression.

What are the potential side effects?

While not explicitly listed here, common side effects from SSRIs can include nausea, headaches, sleep disturbances (like insomnia), fatigue or drowsiness; sexual dysfunction; dry mouth; blurred vision; and weight gain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant and use non-hormonal birth control methods.

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I am between 21 and 60 years old and can legally consent.

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My blood counts are within normal range and I haven't donated blood in the last 8 weeks.

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I have never had a concussion that caused me to black out for more than 10 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with SSRIExperimental Treatment1 Intervention

Depressed participants will receive 8 weeks of treatment with one of the following serotonin-specific reuptake inhibitors: fluoxetine (Prozac®), sertraline (Zoloft®), citalopram (Celexa®), escitalopram (Lexapro®) The specific drug used for treatment will be selected by the study clinician based on clinical interviews and the participants preferences. Participants will be monitored for response and side effects by study clinician and will return after 8 weeks for a follow up study visit.

0 / 4Eligibility criteria met