Effect of supplementary oral 5-hydroxytryptophan on severity of depression in patients on chronic selective serotonin reuptake inhibitors; a clinical trial

The effect of supplementary oral 5-hydroxytriptophan plus other essential elements (Dr Daniel capsule) on severity of depression, quality of life and the level of urinary 5-Hydroxyindoleacetic acid in patients with major depression on chronic selective serotonin reuptake inhibitors

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001275752

Enrollment

240

Registered

2013-11-19

Start date

2013-12-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Some studies have proposed that using SSIRs (for example in patients with major depression) will gradually exhaust the reserve of serotonin in the body of receivers. So, supplementing these patients with serotonin (or its precursor, 5-HTP) along with essential cofactors in its metabolism may be helpful. This is the first clinical trial ever in this regard.

Interventions

Three groups of patients with major depression (80 patients in each group) on chronic (over 6 months) selective serotonin reuptake inhibitors (SSIRs) will randomly receive daily oral 5-hydroxytriptophan (5-HTP) 50 or 300 mg plus other elements including 500 mg (in cases on 50 mg 5-HTP) or 3000 mg (in cases on 300 mg 5-HTP) L-tyrosin, 500 mg cysteine, 1.5 mg pyrodoxine and 0.05 mg selenium (Dr Daniel capsule) in the intervention groups; or oral placebo (glucose) in the control group for 3 consecutive months. Exercise and diet profiles will be similar during the study period in all three groups. Adherence interventions will include monthly instruction in forms of oral and written material. Adherence to taking medication will be monitored by drug capsule return monthly.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

Patients with major depression on chronic (over 6 months) selective serotonin reuptake inhibitors

Exclusion criteria

Patients on anti-depressive medications other than SSIRs, patients with carcinoids, renal disease, or malabsorption.

Outcome results