Combining Fluoxetine with ATP for Rapid Depression Relief
Fluoxetine Combined With ATP Rapidly Improves Moderate to Severe Depression: a Pilot Study
This study is testing if adding ATP to fluoxetine can help people with moderate to severe depression feel better faster than just taking fluoxetine alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05431413 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effectiveness of combining fluoxetine, a common antidepressant, with ATP in patients suffering from moderate to severe depression. It is a randomized, double-blind, placebo-controlled trial where participants are assigned to one of three groups: fluoxetine with ATP, fluoxetine with phosphocreatine, or fluoxetine with a saline placebo. The study aims to assess the safety and efficacy of these combinations by evaluating cognitive and brain function at multiple time points after treatment. The goal is to determine if the addition of ATP can lead to a faster improvement in depressive symptoms compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who meet the DSM-V criteria for moderate to severe depression and have not used certain psychiatric medications in the month prior to the study.
Not a fit: Patients with other major mental disorders, neurological disorders, or those at high risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more rapid and effective treatment option for patients with moderate to severe depression.
How similar studies have performed: While the combination of fluoxetine with ATP is a novel approach, previous studies have shown promise in using adjunctive therapies for depression, though this specific combination has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Bin Zhang, MD & PhD — Nanfang Hospital, Southern Medical University
- Study coordinator: Bin Zhang, MD & PhD
- Email: zhang73bin@hotmail.com
- Phone: 86-020-62786731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.