Trial to Evaluate Efficacy of Pharmacogenetic Information Obtained With NEUROPHARMAGEN in Treatment of MDD Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT02529462
• Date of registration: 19/08/2015
• Prospective Registration: No
• Primary sponsor: AB Biotics, SA
• Public title: Trial to Evaluate Efficacy of Pharmacogenetic Information Obtained With NEUROPHARMAGEN in Treatment of MDD Patients
• Scientific title: Randomised, Controlled, Parallel Clinical Trial on the Efficacy of Pharmacogenetic Information Obtained With NEUROFARMAGEN in the Treatment of Patients With Mental Disorders
• Date of first enrolment: July 2014
• Target sample size: 521
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02529462
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Spain

Contacts

• Name: José Manuel Menchón, MD
• Affiliation: Hospital Universitari de Bellvitge

• Name: Víctor Pérez, MD
• Affiliation: Hospital del Mar in Barcelona

Key inclusion & exclusion criteria

Inclusion Criteria at pre-randomization visit:

- Patients with diagnosed for major depressive disorder according to DSM-IV-TR criteria

- Patients who give their written informed consent to participate in the study. In the
case of disabled patients, informed consent from the legal representative or
responsible relative.

- Patients with a doctor-rated Clinical Global Impression - Severity Scale (CGI-S) score
equal to or greater than 4.

- Patients who are diagnosed de novo who, in the doctor's opinion, require medication or
are receiving treatment and require an antidepressant, antipsychotic or mood
stabiliser as a replacement or additional medication

Exclusion Criteria at pre-randomization visit:

- Patients who, in the investigator's opinion, will not be able to complete the study
follow-up.

- Patients who are actively taking part in or who have taken part in another clinical
trial in the past 3 months.

- Patients who are pregnant or breast-feeding, or patients who plan to become pregnant
within the next 12 months.

- Patients who are or who require treatment with quinidine, cinacalcet and/or
terbinafine (potent CYP2D6 inhibitors).

Inclusion criteria at randomization visit:

Patients who meet the screening criteria at the pre-randomisation visit must meet the
following criteria at visit 1 to be randomised. Otherwise, they will be excluded from the
active follow-up phase. The criteria are:

- Patients with a PGI-I score of 4 or more.

- Patients with a CGI score of 4 or more.

- Patients whose dose of pharmacological treatment, in the doctor's opinion, requires
suppression, replacement, addition or modification with an antidepressant,
antipsychotic or mood stabiliser.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Depressive Disorder, Major

Intervention(s)

Genetic: NEUROPHARMAGEN-Guided Treatment

Drug: Treatment As Usual

Primary Outcome(s)

Sustained response to treatment [Time Frame: 3 months]

Secondary Outcome(s)

Sheehan Disability Inventory (SDI) [Time Frame: 3 months]

Response to treatment [Time Frame: 3 month]

Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) [Time Frame: 3 months]

FIBSER Scale (Frequency, Intensity and Burden of Side Effects Rating) [Time Frame: 3 months]

Hamilton Rating Scale for Depression (HAM-D) [Time Frame: 3 months]

Clinical Global Impression-Severity scale (CGI-S) [Time Frame: 3 months]

Secondary ID(s)

AB-GEN-2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors