Rapid Improvement of Depression of Fluoxetine Combined With ATP or Phosphocreatine

• Sponsor: Nanfang Hospital of Southern Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05431413
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Control group: Fluoxetine and Placebo; Drug: Experimental group: Fluoxetine and ATP; Drug: Experimental group: Fluoxetine and Phosphocreatine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Fluoxetine Combined With ATP or Phosphocreatine Rapidly Improves Moderate to Severe Depression: a Pilot Study
• Actual Study Start Date: Jul 7, 2020
• Anticipated Primary Completion Date: Jul 7, 2023
• Anticipated Study Completion Date: Jul 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group: Fluoxetine and Placebo Fluoxetine(20mg) was used for four weeks once everyday. 0.9% sodium chloride was used for two weeks twice a day.	Drug: Control group: Fluoxetine and Placebo; Fluoxetine and 0.9% sodium chloride was administered intravenously.
Experimental: Experimental group: Fluoxetine and ATP Fluoxetine(20mg) was used for four weeks once everyday. ATP(100mg) was used for two weeks twice a day.	Drug: Experimental group: Fluoxetine and ATP; Fluoxetine and ATP was administered intravenously.
Experimental: Experimental group: Fluoxetine and Phosphocreatine Fluoxetine(20mg) was used for four weeks once everyday. Phosphocreatine(1g) was used for two weeks twice a day.	Drug: Experimental group: Fluoxetine and Phosphocreatine; Fluoxetine and Phosphocreatine was administered intravenously.

Outcome Measures

Primary Outcome Measures

1. Hamilton Depression Scale [Baseline and one, two, four weeks after treatment]

   Changes in Hamilton Depression Scale

Secondary Outcome Measures

1. Patient Health Questionnaire [Baseline and one, two, four weeks after treatment]

   Changes in Patient Health Questionnaire

2. Antidepressants Side Effects [One, two, four weeks after treatment]

   Number of Participants with antidepressants side effects

3. Hamilton Anxiety Scale [Baseline and one, two, four weeks after treatment]

   Changes in Hamilton Anxiety Scale

4. Clinical Global Impression [Baseline and one, two, four weeks after treatment]

   Changes in Clinical Global Impression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

• Nanfang Hospital of Southern Medical University

Investigators

• Principal Investigator: Bin Zhang, MD & PhD, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nanfang Hospital of Southern Medical University
• ClinicalTrials.gov Identifier: NCT05431413
• Other Study ID Numbers: NFEC-202006-K5
• First Posted: Jun 24, 2022
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Depressive Disorder; Phosphocreatine; Fluoxetine

Study Results

No Results Posted as of Jun 24, 2022