Image

Rapid Improvement of Depression of Fluoxetine Combined With ATP

Recruiting
18 - 65 years of age
Both
Phase 2

Powered by AI

Overview

The clinical study is a randomized (1:1:1), double-blind, placebo-controlled clinical study. Recruit patients with moderate to severe depression. After signing the informed consent, patients who meet the inclusion criteria will be randomly assigned to the ATP group (fluoxetine combined with ATP) or phosphocreatine group (fluoxetine combined with phosphocreatine) or control group (fluoxetine combined with 0.9% sodium chloride) to received treatment. Then accessed scale, cognitive function and brain function before treatment and at one, two, and four weeks after treatment to initially explore the safety and efficacy of ATP combined with fluoxetine to rapidly improves moderate to severe depression.

Eligibility

Inclusion Criteria:

  • Meet DSM-V diagnostic criteria for moderate to severe depression.
  • HAMD-24 scores ≥ 20.
  • 18-65 female or male.
  • Subjects who have not used any antipsychotic drugs, antidepressants, mood stabilizers (sodium valproate, lithium carbonate) or fluoxetine treatment within the first month prior to the start of this study
  • Written informed consent.

Exclusion Criteria:

  • Sufferring from various major mental disorders other than depression (such as bipolar disorder, schizophrenia, personality split, etc.).
  • Individuals with neurological disorders such as dementia.
  • Individuals with a high risk of suicide.
  • Pregnant and lactating women.
  • Individuals with alcohol or drug abuse or dependence within one year prior to the start of this study.
  • Contraindications to MRI.
  • Physician evaluation was not suitable for participants in this study.

Study details

Depression

NCT05431413

Nanfang Hospital, Southern Medical University

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.