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Rapid Improvement of Depression of Fluoxetine Combined With ATP or Phosphocreatine

Primary Purpose

Depression

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Control group: Fluoxetine and Placebo
Experimental group: Fluoxetine and ATP
Experimental group: Fluoxetine and Phosphocreatine
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control group: Fluoxetine and Placebo

Experimental group: Fluoxetine and ATP

Experimental group: Fluoxetine and Phosphocreatine

Arm Description

Fluoxetine(20mg) was used for four weeks once everyday. 0.9% sodium chloride was used for two weeks twice a day.

Fluoxetine(20mg) was used for four weeks once everyday. ATP(100mg) was used for two weeks twice a day.

Fluoxetine(20mg) was used for four weeks once everyday. Phosphocreatine(1g) was used for two weeks twice a day.

Outcomes

Primary Outcome Measures

Hamilton Depression Scale
Changes in Hamilton Depression Scale

Secondary Outcome Measures

Patient Health Questionnaire
Changes in Patient Health Questionnaire
Antidepressants Side Effects
Number of Participants with antidepressants side effects
Hamilton Anxiety Scale
Changes in Hamilton Anxiety Scale
Clinical Global Impression
Changes in Clinical Global Impression

Full Information

First Posted
June 12, 2022
Last Updated
June 23, 2022
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05431413
Brief Title
Rapid Improvement of Depression of Fluoxetine Combined With ATP or Phosphocreatine
Official Title
Fluoxetine Combined With ATP or Phosphocreatine Rapidly Improves Moderate to Severe Depression: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
July 7, 2023 (Anticipated)
Study Completion Date
July 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group: Fluoxetine and Placebo
Arm Type
Placebo Comparator
Arm Description
Fluoxetine(20mg) was used for four weeks once everyday. 0.9% sodium chloride was used for two weeks twice a day.
Arm Title
Experimental group: Fluoxetine and ATP
Arm Type
Experimental
Arm Description
Fluoxetine(20mg) was used for four weeks once everyday. ATP(100mg) was used for two weeks twice a day.
Arm Title
Experimental group: Fluoxetine and Phosphocreatine
Arm Type
Experimental
Arm Description
Fluoxetine(20mg) was used for four weeks once everyday. Phosphocreatine(1g) was used for two weeks twice a day.
Intervention Type
Drug
Intervention Name(s)
Control group: Fluoxetine and Placebo
Intervention Description
Fluoxetine and 0.9% sodium chloride was administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Experimental group: Fluoxetine and ATP
Intervention Description
Fluoxetine and ATP was administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Experimental group: Fluoxetine and Phosphocreatine
Intervention Description
Fluoxetine and Phosphocreatine was administered intravenously.
Primary Outcome Measure Information:
Title
Hamilton Depression Scale
Description
Changes in Hamilton Depression Scale
Time Frame
Baseline and one, two, four weeks after treatment
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire
Description
Changes in Patient Health Questionnaire
Time Frame
Baseline and one, two, four weeks after treatment
Title
Antidepressants Side Effects
Description
Number of Participants with antidepressants side effects
Time Frame
One, two, four weeks after treatment
Title
Hamilton Anxiety Scale
Description
Changes in Hamilton Anxiety Scale
Time Frame
Baseline and one, two, four weeks after treatment
Title
Clinical Global Impression
Description
Changes in Clinical Global Impression
Time Frame
Baseline and one, two, four weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Zhang, MD & PhD
Phone
86-020-62786731
Email
zhang73bin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meilei Su, MD
Phone
86-020-62786731
Email
sumeilei@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Zhang, MD & PhD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Zhang, MD＆PHD
Phone
86-020-62786731
Email
zhang73bin@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Rapid Improvement of Depression of Fluoxetine Combined With ATP or Phosphocreatine

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