Clinical trial NCT05431413: Rapid Improvement of Depression of Fluoxetine Combined With ATP
Official title: Fluoxetine Combined With ATP Rapidly Improves Moderate to Severe Depression: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Depression
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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.

Primary outcomes:
measure: Hamilton Depression Scale
timeFrame: Baseline and one, two, four weeks after treatment
Secondary outcomes:
measure: structural brain networks
timeFrame: Baseline and two, four weeks after treatment
measure: functional brain networks
timeFrame: Baseline and two and four weeks after treatment
measure: Hamilton Anxiety Scale
timeFrame: Baseline and one, two, four weeks after treatment
measure: Clinical Global Impression
timeFrame: Baseline and one, two, four weeks after treatment
measure: Snaith-Hamilton Pleasure Scale
timeFrame: Baseline and one, two, four weeks after treatment
measure: Insomnia Severity Index
timeFrame: Baseline and one, two, four weeks after treatment
measure: Patient Health Questionnaire
timeFrame: Baseline and one, two, four weeks after treatment
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Baseline and one, two, four weeks after treatment
measure: Antidepressants Side Effects
timeFrame: Baseline and one, two, four weeks after treatment
measure: C-reaction protein
timeFrame: Baseline and two and four weeks after treatment
measure: Tumor Necrosis Factor α
timeFrame: Baseline and two and four weeks after treatment
measure: interleukin- 6
timeFrame: Baseline and two and four weeks after treatment
measure: N-back task
timeFrame: Baseline and two and four weeks after treatment
measure: Stroop task
timeFrame: Baseline and two and four weeks after treatment
measure: Psychomotor vigilance task
timeFrame: Baseline and two and four weeks after treatment
measure: Attention network test
timeFrame: Baseline and two and four weeks after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Bin Zhang, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References: