Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06254612

A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

This is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IMA Clinical Research, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Males and females, aged 18 to 65 years, inclusive.
  • Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
  • In generally good physical health, in the opinion of the Investigator.
  • Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.

Key Exclusion Criteria:

  • Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
  • A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
  • Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
  • Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) >160 mmHg or consistent sitting diastolic blood pressure (DBP) >95 mmHg despite present therapy.
  • Screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, thyroid function, and urinalysis).

Treatment and study plan

SP-624

Drug

Once daily oral administration of two capsules totaling 20 mg/day

Placebo

Drug

Once daily oral administration of two matching placebo capsules

Primary outcomes

  1. Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

    Time frame: Baseline to Week 4

    The MADRS is a 10-item depression rating scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The toal score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.

Secondary outcomes

  1. Change from Baseline in the Clinical Global Impression - Severity (CGI-S) score.

    Time frame: Baseline to Weeks 1-4 and 1- and 2- Week Follow-up

    The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents "normal" and 7 represents "most extremely ill".

  2. Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score.

    Time frame: Baseline to Weeks 1-4 and 1- and 2- Week Follow-up

    The QIDS-SR is a 16-item self-reported scale where each item has a 4-point scale where 0 represents least impact scores while 3 represents greatest impact scores. Some questions are linked. The total score ranges from 0 to 27 where a higher score indicates more depression.

  3. Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

    Time frame: Baseline to Weeks 1-3 and 1- and 2- Week Follow-up

    The MADRS is a 10-item depression rating scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The toal score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.

  4. Change from Baseline in 17-item-Hamilton Depression Rating Scale (HAM-D-17) total score.

    Time frame: Baseline to Weeks 2 and 4

    The 17-item HAM-D is used to assess the severity of depression. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=No difficulty/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.

  5. Change from Baseline in Sheehan Disability Scale (SDS) total score.

    Time frame: Baseline to Weeks 2 and 4

    The SDS is a 3-part scale that measures the degree of disruption on work, social and family life using an 11-point scale where 0 represents "no disruption" and 10 represents "extreme disruption". In addition to the 11-point scale, participants are asked to indicate the number of days in the past week that were "lost" and numbers of days that were "underproductive". The results of these questions have a range from 0 to 7. A total global functioning impairment score can be utilized by summing the scores from work, social and family life scales for a value range from 0 to 30.

  6. Change from Baseline in Symbol Digit Modalities Test (SDMT) score.

    Time frame: Baseline to Weeks 2 and 4

    The SDMT is an assessment of complex scanning and visual tracking requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The SDMT measures the time to pair abstract symbols with specific numbers. The number of correct substitutions within 90 seconds is recorded and the total score is derived from the total number of correct responses with a minimum possible score of 0 and maximum of 110 where high scores indicate better outcome.

  7. Incidence rates of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to withdrawal from study.

    Time frame: Baseline to Weeks 1-4 and 1- and 2- Week Follow up

Sponsors and collaborators

Lead sponsor

Sirtsei Pharmaceuticals, Inc.

Industry

Collaborators

  • Rho, Inc.

Registry information

Official study title

A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.