Candesartan as an Adjunctive Treatment for Bipolar Depression

NCT04430959 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: HSC-MS-19-1046
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety and tolerability of Candesartan when used in patients with Bipolar Disorder, in addition to their medication treatment.

Conditions

Bipolar Disorder Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS) scores at the end of each treatment period.

  MADRS scores range from 0-60; higher scores indicate a higher level of severity of depressive symptoms. Response will be defined as a decrease equal or higher than 50% in the total MADRS score between the baseline and the 4th week of each treatment period.

  Four weeks

Secondary Outcomes (4)

• Hamilton Anxiety Rating Scale (HAM-A) scores at the end of each treatment period.

  Four weeks

• Clinical Global Impression - Severity scale (CGI-S) scores at the end of each treatment period.

  Four weeks

• Functional Assessment Screening Tool scores at the end of each treatment period.

  Four weeks

• Young Mania Rating Scale (YMRS) at the end of each treatment period

  Four weeks

Study Arms (2)

Candesartan first then Placebo

EXPERIMENTAL

4 weeks of candesartan with crossover to the other.

Drug: Candesartan; Drug: Placebo

Placebo first then Candesartan

PLACEBO COMPARATOR

4 weeks of placebo with crossover to the other.

Drug: Candesartan; Drug: Placebo

Interventions

Candesartan DRUG

Candesartan 4 mg, tablets, orally, once daily for 4 weeks

Also known as: Atacand

Candesartan first then Placebo; Placebo first then Candesartan

Placebo DRUG

Candesartan placebo-matching tablets, orally, once daily for 4 weeks

Candesartan first then Placebo; Placebo first then Candesartan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years.
• A diagnosis of BD type I or II according to DSM-5 criteria, established through the administration of the MINI.
• Currently in a depressive episode, based on DSM-5 criteria.
• MADRS \>20 at entry in the study.
• No history of hypertension, diabetes, stroke, liver, kidney, heart disease, bleeding disorders, cancer, hypothyroidism, auto-immune diseases, and any brain disorder (seizure disorder, stroke, dementia, or neurodegenerative diseases), as well as other conditions that could impact patient's safety associated with participation in the study.
• On therapeutic doses of a mood stabilizing drug (anticonvulsants or atypical antipsychotics, but not lithium) or combinations of medications (including antidepressants, as long as receiving at least one mood stabilizing agent) for at least two weeks.
• Allowed psychiatric comorbid conditions, such as anxiety disorders, PTSD and past history of substance use (as long as do NOT meet abuse or dependence criteria according to the SCID-I in the past 2 months).

You may not qualify if:

• Current use of angiotensin receptor antagonists, angiotensin converting enzyme inhibitors. (ACE inhibitors), or a history of allergies or poor tolerability to those medications
• Current use of lithium or any other medications that could implicate in potentially dangerous. interactions with candesartan, based on available literature and the investigator's judgement.
• Pregnancy or current breastfeeding.
• Acute systemic infections or other acute medical conditions at the time of study entry.
• Acute suicidal or homicidal ideation or other imminent concerns about safety, based on the investigator's judgement and/or on a score equal or higher than 4 in the item 10 of the MADRS.
• Family history of hereditary neurologic disorder.
• Unable to give informed consent for any reason.
• Floating metallic objects in the body.
• Positive urine drug screening at the time of study entry.
• Current or previous diagnosis of intellectual disability, learning disability, or other severe neurodevelopmental disorders.
• History of traumatic brain injury or head trauma with loss of consciousness for more than 30 minutes.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

candesartan; candesartan cilexetil

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Marsal Sanches, MD PhD

  University of Texas, Science Center at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, UT Health Center of Excellence on Mood Disorders

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 16, 2020
• Study Start: October 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

US (1)