Rapid Improvement of Depression of Fluoxetine Combined With ATP or Phosphocreatine

• Status: Recruiting
• Trial end date: 2023-07-07
• Target enrollment: 0
• Participant gender: All

Summary

The clinical study is a randomized (2:1), 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 experimental group (fluoxetine combined with ATP or phosphocreatine) and the control group (fluoxetine combined with 0.9% sodium chloride) to received treatment. Then accessed HAMD-24, HAMA, and PHQ-9 before treatment and at one, two, and four weeks after treatment to initially explore the safety and efficacy of ATP and phosphocreatine combined with fluoxetine to rapidly improves moderate to severe depression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: Fluoxetine; Phosphocreatine

Criteria

Inclusion Criteria:

• Met DSM-V diagnostic criteria for moderate to severe depression.

• HAMD-24 scores > 20.

• 18-65 female or male.

• Written informed consent.

Exclusion Criteria:

• Participated in other clinical trials within four weeks.

• Family history of schizophrenia.

• Experienced life events that caused severe psychological trauma within six months and were diagnosed with post-traumatic stress syndrome (PTSD).

• Pregnant and lactated women.

• Thyroid dysfunction.

• Severe dementia, aphasia and other serious physical diseases that affected the expression of depression .

• Various mental disorders other than depressive disorder (such as bipolar disorder, schizophrenia, etc.).

• Serious heart, liver, lung, kidney and other systemic diseases.

• Brain diseases (such as epilepsy, acute phase of stroke, multiple sclerosis, brain tumors, etc.).

• Serious inflammatory diseases or patients was receiving anti-inflammatory treatment.

• Took anti-arrhythmia drugs, hypoglycemic drugs and tryptophan.

• History of drug addiction or dependence within 6 months.

• Have suicide plans or suicide behavior.

• Patients who were unwilling to accept this experiment for various reasons or had difficulty completing this experiment.